20 Blas Jobs

About Infodesk www.infodesk.com Infodesk is the leading enterprise intelligence management SaaS platform, serving the top 100 companies across global life sciences, government, professional, and investment services. InfoDesk's proprietary "Smarter Data" technology gathers, normalizes, enriches, and summarizes content in real time from external and internal sources to deliver business-critical insights that help clients increase their competitive awareness, mitigate risks, and make confident data-driven strategic decisions. InfoDesk is looking for a Senior Regulatory Delivery Analyst to provide and manage projects that meet the custom information needs of high-profile, clientele of global pharmaceutical and biotech companies. This is a unique role and to be successful, you will have a deep understanding of regulatory submissions and requirements or product development, including research, clinical trials, manufacturing practices, regulations and approvals processes. Responsibilities: Ensure completion of regulatory projects for InfoDesk’s customers in line with customer scope Work directly with InfoDesk internal stake holders establish and enforce scope of work and enable InfoDesk’s teams to fulfill services according to scope Research publicly available websites from Regulatory Authorities and other relevant websites to identify and manage the information strategy process. Create searches and apply standard “search logic” (including Boolean) to find certain websites that provide information on applicable laws and regulations. Evaluate applicable laws and regulations to determine impact on company and client activities Identify and interpret relevant regulatory guidelines, as they relate to InfoDesk client projects Advise others on regulatory and compliance matters, as they relate to InfoDesk client projects Explain regulations, policies, or procedures, as they relate to Infodesk stakeholders Coordinate regulatory documentation activities, in accordance to client project scopes Provide technical review of data orreports Maintain data in information systems or databases Ability to navigate the Web and tools to consume content, like RSS, Google Alerts etc. Must have: BA/BS in scientific/engineering/healthcare discipline, Masters, PharmD or Ph.D preferred 10-18 years in the Pharmaceutical Industry orregulatory strategy or similar training / experience Strong knowledge of current North America and EU regulations, and familiarity with internationalregulations. Knowledge of and broad experience with regulatory procedures and legislation for drug/device development (specifically GxPs), product registration, line extension and license maintenance (US, CA & EU required). Understanding of regulatory controls and marketing pathways INDs/IDEs/BLAs/NDAs/510(k)s/PMAs, marketing applications and other regulatory submissions and pathways (orphan drug, PRIME, IRP etc) Ability to manage complex projects and timelines in a multinational/multicultural team environment

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Document Specialist position is responsible for formatting, reviewing compiling, and processing regulatory documents (both Word and PDF) in support of electronic publishing activities with a focus on quality, accuracy, and efficiency providing publishing support to ProPharma clients. Essential Functions Directly supports electronic submission of regulatory documents / applications including IND, CTA, NDA, BLA, MAA, etc. through formatting, processing, and compilation of Word and PDF documents to the appropriate client specifications. Formats and reviews Word documents in preparation for publishing, in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. Performs document conversion to PDF, and formats and reviews PDF documents to specification (for eCTD compliance), including bookmarks, hyperlinks, keyword linking, document properties, etc., in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. Compiles regulatory documents / reports, gathering all required documents, within all established timelines. Publishes regulatory documents according to all relevant guidelines and specifications for eCTD submission, performing all relevant pre- and post-publishing quality review checks. Prepares and transfers final documents for publishing, supporting client and internal team during submission preparation, routing documents for review and approval, where applicable. Adheres to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2) / M4, EU MDR / IVDR, Company standard operating procedures, and client standards instructions. Supports multiple publishing activities / projects simultaneously and manages own workload, ensuring completion of all projects within established timelines, immediately escalating any issues. Manages client expectations and interacts and communicates directly with clients to ensure accuracy and maintain timeline integrity. Performs peer / quality review of documents processed by other team members as requested. Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to document publishing. Brings issues and potential concerns to line manager / client oversight manager’s attention in a timely manner. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). May occasionally be required to work outside of normal business hours to support client’s needs. Other duties as assigned. Necessary Skills And Abilities Extensive knowledge and mastery of Microsoft Word (advanced level formatting). Extensive knowledge and experience with Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems (e.g., ISI Toolbox, Core Dossier). Excellent problem-solving skills, including the ability to think outside the box. Ability to work on multiple projects at a time. Exceptional project management and communication skills with a high attention to detail and quality. English language proficiency. Ability to think proactively and take initiative, with a willingness to take on new challenges. Ability to work independently and contact management team proactively when additional support and resources are needed. Ability to work effectively in a collaborative team environment. Ability to work within established working hours. Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements Bachelor’s degree, preferably in life sciences (or related field). Experience Requirements Minimum 3 years of experience in document publishing and / or formatting. Pharmaceutical / biotech industry experience (specifically, INDs / CTAs, NDAs / BLAs / MAAs) preferred. Other professional and/or educational experience may contribute toward these minimum requirements, as determined on a case-by-case basis. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Position Overview: The Drug Regulatory Affairs Executive plays a critical role in ensuring that pharmaceutical products meet all regulatory requirements. This position involves collaboration with various departments to support the development and approval of drug products, ensuring compliance with local and international regulations. Key Responsibilities: Regulatory Compliance: Ensure that all drug products comply with relevant laws and regulations. Maintain up-to-date knowledge of regulatory changes and industry standards. Submission Management: Prepare and submit regulatory documents (INDs, NDAs, BLAs) to health authorities. Manage timelines and ensure timely submission of all regulatory filings. Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Marketing teams to support product development. Provide regulatory guidance and expertise during product lifecycle management. Clinical Trials: Oversee the regulatory aspects of clinical trial applications. Ensure compliance with Good Clinical Practice (GCP) and related guidelines. Labeling and Product Information: Review product labeling and promotional materials to ensure compliance. Collaborate with marketing to ensure accurate and compliant product information. Audits and Inspections: Prepare for and participate in regulatory inspections and audits. Address findings and implement corrective actions as necessary. Risk Assessment: Conduct risk assessments related to regulatory issues. Develop strategies to mitigate risks associated with product approvals. Qualifications: Education: Bachelor’s degree in Pharmacy, Life Sciences, or related field; advanced degree preferred. Experience: 3-5 years of experience in regulatory affairs within the pharmaceutical industry. Knowledge: In-depth understanding of pharmaceutical regulations, guidelines, and processes (FDA, EMA, etc.). Skills: Strong analytical and problem-solving abilities. Excellent communication and interpersonal skills. Proficiency in regulatory submission software and Microsoft Office Suite. Personal Attributes: Detail-oriented with a strong commitment to compliance. Ability to work independently and as part of a team. Strong organizational and project management skills. Career Path: Potential advancement opportunities include Senior Regulatory Affairs Executive, Regulatory Affairs Manager, or Director of Regulatory Affairs. Location: In Person. Application Process: Interested candidates should submit their CV and a cover letter to office.ssventures@gmail.com or whatsup ur CV on +91 8755041400. Job Types: Full-time, Permanent Pay: ₹25,000.00 - ₹40,000.00 per month Benefits: Cell phone reimbursement Health insurance Internet reimbursement Schedule: Day shift Supplemental Pay: Performance bonus Yearly bonus Experience: Regulatory reporting: 3 years (Required) Work Location: In person

Job requisition ID :: 84858 Date: Jun 23, 2025 Location: Bengaluru Designation: Senior Manager Entity: Key Responsibilities may include: Solution Design and Architecture Lead development of RFP response, end-to-end solution approach, solution storyboards, Total Cost of Ownership (TCO) analysis, and review pricing model inputs/deal shaping. Create differentiated deal structures and commercial models, embedding multitower synergies during solutioning. Create estimation frameworks and pricing model frameworks. Review and provide feedback on key contracting terms and Service Level Agreements (SLAs). Client Interaction and Collaboration Articulate integrated solutions with clients by leading solution presentations and creating value propositions for client requirements. Lead the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Lead and run solution review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loop. Provide leadership and work closely with other industry Subject Matter Experts to develop business-aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs).

Summary Position Summary Role- Operate CoE – Solution Hub Senior Solution Architect Work You’ll Do: As a Senior Solution Architect within the Operate Solution Hub, you will be responsible for owning the end-to-end solution design and architecture for large and complex deals (>$50M Total Contract Value). These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture Develop solution storyboards, Total Cost of Ownership (TCO) analysis, and review pricing model inputs. Create differentiated deal structures and commercial models, embedding multitower synergies during solutioning. Create estimation frameworks and pricing model frameworks. Review and provide feedback on key contracting terms and Service Level Agreements (SLAs). Client Interaction and Collaboration Articulate integrated solutions with clients by leading solution presentations and creating value propositions for client requirements. Lead the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Lead and run solution review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loop. Provide leadership and work closely with other industry Subject Matter Experts to develop business-aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs). Qualifications Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 15 years of experience Unyielding focus on quality results (analyses and deliverables) Multi-tower experience with solutioning and commercial models Strong analytical and consulting skills, including experience in business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets, estimation approaches, and solution integration Top-notch written and oral communication/presentation skills with the ability to put together cohesive decks Advanced Excel skills Able to lead a matrixed team during deal pursuits Location: USI Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 302290 Show more Show less

Summary Position Summary Role- Operate CoE – Solution Hub Senior Solution Architect Work You’ll Do: As a Senior Solution Architect within the Operate Solution Hub, you will be responsible for owning the end-to-end solution design and architecture for large and complex deals (>$50M Total Contract Value). These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture Develop solution storyboards, Total Cost of Ownership (TCO) analysis, and review pricing model inputs. Create differentiated deal structures and commercial models, embedding multitower synergies during solutioning. Create estimation frameworks and pricing model frameworks. Review and provide feedback on key contracting terms and Service Level Agreements (SLAs). Client Interaction and Collaboration Articulate integrated solutions with clients by leading solution presentations and creating value propositions for client requirements. Lead the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Lead and run solution review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loop. Provide leadership and work closely with other industry Subject Matter Experts to develop business-aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs). Qualifications Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 15 years of experience Unyielding focus on quality results (analyses and deliverables) Multi-tower experience with solutioning and commercial models Strong analytical and consulting skills, including experience in business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets, estimation approaches, and solution integration Top-notch written and oral communication/presentation skills with the ability to put together cohesive decks Advanced Excel skills Able to lead a matrixed team during deal pursuits Location: USI Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 302290 Show more Show less

Summary Position Summary Role- Operate CoE – Solution Hub Senior Solution Architect Work You’ll Do: As a Senior Solution Architect within the Operate Solution Hub, you will be responsible for owning the end-to-end solution design and architecture for large and complex deals (>$50M Total Contract Value). These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture Develop solution storyboards, Total Cost of Ownership (TCO) analysis, and review pricing model inputs. Create differentiated deal structures and commercial models, embedding multitower synergies during solutioning. Create estimation frameworks and pricing model frameworks. Review and provide feedback on key contracting terms and Service Level Agreements (SLAs). Client Interaction and Collaboration Articulate integrated solutions with clients by leading solution presentations and creating value propositions for client requirements. Lead the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Lead and run solution review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loop. Provide leadership and work closely with other industry Subject Matter Experts to develop business-aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs). Qualifications Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 15 years of experience Unyielding focus on quality results (analyses and deliverables) Multi-tower experience with solutioning and commercial models Strong analytical and consulting skills, including experience in business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets, estimation approaches, and solution integration Top-notch written and oral communication/presentation skills with the ability to put together cohesive decks Advanced Excel skills Able to lead a matrixed team during deal pursuits Location: USI Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 302290 Show more Show less

Position Summary Junior Solution Specialist – Senior Consultant Work You’ll Do: As a Junior Solution Specialist within the Operate Solution Hub, you will assist in designing and implementing technical solutions for market offerings inside your own Offering Portfolio, with a strong emphasis on estimation and pricing. These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture analysis, business case development, and reviewing pricing model inputs. Assist in creating and refining deal shapes with a focus on pricing strategies and cost optimization. Bring in multi-offering synergies in deal solutioning from the OP perspective, with a particular focus on estimation and pricing integration. When needed, help provide feedback on key contracting terms and Service Level Agreements (SLAs) under the guidance of senior specialists. Contribute to development of estimation frameworks and pricing model frameworks. Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in development of presentations. Embed multi-offering synergies and create value propositions for client requirements, emphasizing estimation and pricing benefits. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in pricing review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loops, ensuring pricing strategies are maintained. Collaborate with other industry Subject Matter Experts to come up with business aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs), with a focus on pricing efficiency. Qualifications Senior Consultant Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 6-8 years of experience Focused on quality results (analyses and deliverables) Multi-offering experience with solutioning and commercial models Strong analytical and consulting skills, including experience in supporting business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets and solution integration Written and oral communication skills with the ability to put together cohesive decks Advanced Excel skills Strong expertise in pricing strategies and cost optimization Location: USI How you’ll grow At Deloitte, we’ve invested a great deal to create a rich environment in which our professionals can grow. We provide our professionals with a variety of learning and networking opportunities, some of which are: Intensive trainings on latest technologies from eminent external trainers. Internal trainings and workshops. Subscriptions to prominent online training platforms, such as LinkedIn. Hackathons and tech challenges to exercise your front-end skills. Freedom to adopt and use the latest technologies in your live projects. Travel opportunity (wherever possible) to work at the client’s location or at our global offices. Apart from the above, you will have access to DU: The Leadership Center in India, our state-of-the-art, world-class learning Center in the Hyderabad offices is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Deloitte’s culture Our positive and supportive culture encourages our people to do their best every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer comprehensive well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead happy lives. Learn more about Life at Deloitte. Corporate citizenship Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships that we have with our clients, our people and our communities.We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. #National_Consulting Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301801 Show more Show less

Summary Position Summary Solution Architect - Manager Work You’ll Do: As a Solution Architect within the Operate Solution Hub, you will be responsible for coordinating the design and implementation for large and complex deals ($30-$50M Total Contract Value). These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture Support development of solution storyboards, Total Cost of Ownership (TCO) analysis, and review pricing model inputs/deal shapes. Contribute to the creation of differentiated deal structures and commercial models, embedding multitower synergies during solutioning. Develop estimation frameworks and pricing model frameworks. Work closely with other industry Subject Matter Experts to develop business-aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs). Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in and helping to lead solution presentations. Assist in the creation of value propositions for client requirements. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in solution review meetings with internal stakeholders. Collaborate with Transition and delivery teams on delivery feedback loop. Work closely with other industry SMEs to develop business-aligned metrics, such as BLAs and XLAs. Qualifications Manager Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 8-10 years of experience Focused on quality results (analyses and deliverables) Multi-tower experience with solutioning and commercial models Strong analytical and consulting skills, including experience in business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets, estimation approaches, and solution integration Top-notch written and oral communication/presentation skills with the ability to put together cohesive decks Advanced Excel skills Work within a matrixed team during deal pursuits and adapt to changing project requirements and timelines. Location: USI Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301834 Show more Show less

Position Summary Junior Solution Architect - Manager Work You’ll Do: As a Junior Solution Architect within the Operate Solution Hub, you will assist in the design and implementation of large and complex deals ($10-$30M Total Contract Value). These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture Support development of solution storyboards, Total Cost of Ownership (TCO) analysis, and review pricing model inputs/deal shapes. Contribute to the creation of differentiated deal structures and commercial models, embedding multitower synergies during solutioning. Contribute to development of estimation frameworks and pricing model frameworks. When needed, help provide feedback on key contracting terms and Service Level Agreements (SLAs) under the guidance of senior architects. Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in development of solution presentations. Assist in the creation of value propositions for client requirements. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in solution review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loop. Collaborate with other industry Subject Matter Experts on development of business-aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs). Qualifications Manager Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 6-8 years of experience Focused on quality results (analyses and deliverables) (Preferred) Multi-tower experience with solutioning and commercial models Strong analytical and consulting skills, including experience in supporting business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets and solution integration Written and oral communication skills with the ability to put together cohesive decks Advanced Excel skills Able to work in a fast-paced environment and manage multiple priorities Location: USI How You’ll Grow At Deloitte, we’ve invested a great deal to create a rich environment in which our professionals can grow. We provide our professionals with a variety of learning and networking opportunities, some of which are: Intensive trainings on latest technologies from eminent external trainers. Internal trainings and workshops. Subscriptions to prominent online training platforms, such as LinkedIn. Hackathons and tech challenges to exercise your front-end skills. Freedom to adopt and use the latest technologies in your live projects. Travel opportunity (wherever possible) to work at the client’s location or at our global offices. Apart from the above, you will have access to DU: The Leadership Center in India, our state-of-the-art, world-class learning Center in the Hyderabad offices is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Deloitte’s culture Our positive and supportive culture encourages our people to do their best every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer comprehensive well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead happy lives. Learn more about Life at Deloitte. Corporate citizenship Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships that we have with our clients, our people and our communities.We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. #National_Consulting Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301827 Show more Show less

Position Summary Junior Solution Specialist - Manager Work You’ll Do: As a Junior Solution Specialist within the Operate Solution Hub, you will assist in designing and implementing technical solutions for market offerings inside your own Offering Portfolio, with a strong emphasis on estimation and pricing. These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture analysis, business case development, and reviewing pricing model inputs. Assist in creating and refining deal shapes with a focus on pricing strategies and cost optimization. Bring in multi-offering synergies in deal solutioning from the OP perspective, with a particular focus on estimation and pricing integration. When needed, help provide feedback on key contracting terms and Service Level Agreements (SLAs) under the guidance of senior specialists. Contribute to development of estimation frameworks and pricing model frameworks. Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in development of presentations. Embed multi-offering synergies and create value propositions for client requirements, emphasizing estimation and pricing benefits. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in pricing review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loops, ensuring pricing strategies are maintained. Collaborate with other industry Subject Matter Experts to come up with business aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs) , with a focus on pricing efficiency. Qualifications Manager Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 6-8 years of experience Focused on quality results (analyses and deliverables) Multi-offering experience with solutioning and commercial models Strong analytical and consulting skills, including experience in supporting business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets and solution integration Written and oral communication skills with the ability to put together cohesive decks Advanced Excel skills Strong expertise in pricing strategies and cost optimization Location: USI How you’ll grow At Deloitte, we’ve invested a great deal to create a rich environment in which our professionals can grow. We provide our professionals with a variety of learning and networking opportunities, some of which are: Intensive trainings on latest technologies from eminent external trainers. Internal trainings and workshops. Subscriptions to prominent online training platforms, such as LinkedIn. Hackathons and tech challenges to exercise your front-end skills. Freedom to adopt and use the latest technologies in your live projects. Travel opportunity (wherever possible) to work at the client’s location or at our global offices. Apart from the above, you will have access to DU: The Leadership Center in India, our state-of-the-art, world-class learning Center in the Hyderabad offices is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Deloitte’s culture Our positive and supportive culture encourages our people to do their best every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer comprehensive well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead happy lives. Learn more about Life at Deloitte. Corporate citizenship Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships that we have with our clients, our people and our communities.We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. #National_Consulting Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301830 Show more Show less

Position Summary Junior Solution Specialist – Senior Consultant Work You’ll Do: As a Junior Solution Specialist within the Operate Solution Hub, you will assist in designing and implementing technical solutions for market offerings inside your own Offering Portfolio, with a strong emphasis on estimation and pricing. These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture analysis, business case development, and reviewing pricing model inputs. Assist in creating and refining deal shapes with a focus on pricing strategies and cost optimization. Bring in multi-offering synergies in deal solutioning from the OP perspective, with a particular focus on estimation and pricing integration. When needed, help provide feedback on key contracting terms and Service Level Agreements (SLAs) under the guidance of senior specialists. Contribute to development of estimation frameworks and pricing model frameworks. Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in development of presentations. Embed multi-offering synergies and create value propositions for client requirements, emphasizing estimation and pricing benefits. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in pricing review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loops, ensuring pricing strategies are maintained. Collaborate with other industry Subject Matter Experts to come up with business aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs), with a focus on pricing efficiency. Qualifications Senior Consultant Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 6-8 years of experience Focused on quality results (analyses and deliverables) Multi-offering experience with solutioning and commercial models Strong analytical and consulting skills, including experience in supporting business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets and solution integration Written and oral communication skills with the ability to put together cohesive decks Advanced Excel skills Strong expertise in pricing strategies and cost optimization Location: USI How you’ll grow At Deloitte, we’ve invested a great deal to create a rich environment in which our professionals can grow. We provide our professionals with a variety of learning and networking opportunities, some of which are: Intensive trainings on latest technologies from eminent external trainers. Internal trainings and workshops. Subscriptions to prominent online training platforms, such as LinkedIn. Hackathons and tech challenges to exercise your front-end skills. Freedom to adopt and use the latest technologies in your live projects. Travel opportunity (wherever possible) to work at the client’s location or at our global offices. Apart from the above, you will have access to DU: The Leadership Center in India, our state-of-the-art, world-class learning Center in the Hyderabad offices is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Deloitte’s culture Our positive and supportive culture encourages our people to do their best every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer comprehensive well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead happy lives. Learn more about Life at Deloitte. Corporate citizenship Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships that we have with our clients, our people and our communities.We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. #National_Consulting Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301801 Show more Show less

Position Summary Junior Solution Specialist - Manager Work You’ll Do: As a Junior Solution Specialist within the Operate Solution Hub, you will assist in designing and implementing technical solutions for market offerings inside your own Offering Portfolio, with a strong emphasis on estimation and pricing. These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture analysis, business case development, and reviewing pricing model inputs. Assist in creating and refining deal shapes with a focus on pricing strategies and cost optimization. Bring in multi-offering synergies in deal solutioning from the OP perspective, with a particular focus on estimation and pricing integration. When needed, help provide feedback on key contracting terms and Service Level Agreements (SLAs) under the guidance of senior specialists. Contribute to development of estimation frameworks and pricing model frameworks. Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in development of presentations. Embed multi-offering synergies and create value propositions for client requirements, emphasizing estimation and pricing benefits. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in pricing review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loops, ensuring pricing strategies are maintained. Collaborate with other industry Subject Matter Experts to come up with business aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs) , with a focus on pricing efficiency. Qualifications Manager Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 6-8 years of experience Focused on quality results (analyses and deliverables) Multi-offering experience with solutioning and commercial models Strong analytical and consulting skills, including experience in supporting business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets and solution integration Written and oral communication skills with the ability to put together cohesive decks Advanced Excel skills Strong expertise in pricing strategies and cost optimization Location: USI How you’ll grow At Deloitte, we’ve invested a great deal to create a rich environment in which our professionals can grow. We provide our professionals with a variety of learning and networking opportunities, some of which are: Intensive trainings on latest technologies from eminent external trainers. Internal trainings and workshops. Subscriptions to prominent online training platforms, such as LinkedIn. Hackathons and tech challenges to exercise your front-end skills. Freedom to adopt and use the latest technologies in your live projects. Travel opportunity (wherever possible) to work at the client’s location or at our global offices. Apart from the above, you will have access to DU: The Leadership Center in India, our state-of-the-art, world-class learning Center in the Hyderabad offices is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Deloitte’s culture Our positive and supportive culture encourages our people to do their best every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer comprehensive well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead happy lives. Learn more about Life at Deloitte. Corporate citizenship Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships that we have with our clients, our people and our communities.We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. #National_Consulting Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301830 Show more Show less

Position Summary Junior Solution Architect - Manager Work You’ll Do: As a Junior Solution Architect within the Operate Solution Hub, you will assist in the design and implementation of large and complex deals ($10-$30M Total Contract Value). These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture Support development of solution storyboards, Total Cost of Ownership (TCO) analysis, and review pricing model inputs/deal shapes. Contribute to the creation of differentiated deal structures and commercial models, embedding multitower synergies during solutioning. Contribute to development of estimation frameworks and pricing model frameworks. When needed, help provide feedback on key contracting terms and Service Level Agreements (SLAs) under the guidance of senior architects. Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in development of solution presentations. Assist in the creation of value propositions for client requirements. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in solution review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loop. Collaborate with other industry Subject Matter Experts on development of business-aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs). Qualifications Manager Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 6-8 years of experience Focused on quality results (analyses and deliverables) (Preferred) Multi-tower experience with solutioning and commercial models Strong analytical and consulting skills, including experience in supporting business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets and solution integration Written and oral communication skills with the ability to put together cohesive decks Advanced Excel skills Able to work in a fast-paced environment and manage multiple priorities Location: USI How You’ll Grow At Deloitte, we’ve invested a great deal to create a rich environment in which our professionals can grow. We provide our professionals with a variety of learning and networking opportunities, some of which are: Intensive trainings on latest technologies from eminent external trainers. Internal trainings and workshops. Subscriptions to prominent online training platforms, such as LinkedIn. Hackathons and tech challenges to exercise your front-end skills. Freedom to adopt and use the latest technologies in your live projects. Travel opportunity (wherever possible) to work at the client’s location or at our global offices. Apart from the above, you will have access to DU: The Leadership Center in India, our state-of-the-art, world-class learning Center in the Hyderabad offices is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Deloitte’s culture Our positive and supportive culture encourages our people to do their best every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer comprehensive well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead happy lives. Learn more about Life at Deloitte. Corporate citizenship Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships that we have with our clients, our people and our communities.We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. #National_Consulting Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301827 Show more Show less

Position Summary Junior Solution Architect - Manager Work You’ll Do: As a Junior Solution Architect within the Operate Solution Hub, you will assist in the design and implementation of large and complex deals ($10-$30M Total Contract Value). These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture Support development of solution storyboards, Total Cost of Ownership (TCO) analysis, and review pricing model inputs/deal shapes. Contribute to the creation of differentiated deal structures and commercial models, embedding multitower synergies during solutioning. Contribute to development of estimation frameworks and pricing model frameworks. When needed, help provide feedback on key contracting terms and Service Level Agreements (SLAs) under the guidance of senior architects. Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in development of solution presentations. Assist in the creation of value propositions for client requirements. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in solution review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loop. Collaborate with other industry Subject Matter Experts on development of business-aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs). Qualifications Manager Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 6-8 years of experience Focused on quality results (analyses and deliverables) (Preferred) Multi-tower experience with solutioning and commercial models Strong analytical and consulting skills, including experience in supporting business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets and solution integration Written and oral communication skills with the ability to put together cohesive decks Advanced Excel skills Able to work in a fast-paced environment and manage multiple priorities Location: USI How You’ll Grow At Deloitte, we’ve invested a great deal to create a rich environment in which our professionals can grow. We provide our professionals with a variety of learning and networking opportunities, some of which are: Intensive trainings on latest technologies from eminent external trainers. Internal trainings and workshops. Subscriptions to prominent online training platforms, such as LinkedIn. Hackathons and tech challenges to exercise your front-end skills. Freedom to adopt and use the latest technologies in your live projects. Travel opportunity (wherever possible) to work at the client’s location or at our global offices. Apart from the above, you will have access to DU: The Leadership Center in India, our state-of-the-art, world-class learning Center in the Hyderabad offices is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Deloitte’s culture Our positive and supportive culture encourages our people to do their best every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer comprehensive well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead happy lives. Learn more about Life at Deloitte. Corporate citizenship Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships that we have with our clients, our people and our communities.We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. #National_Consulting Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301827 Show more Show less

Position Summary Junior Solution Specialist – Senior Consultant Work You’ll Do: As a Junior Solution Specialist within the Operate Solution Hub, you will assist in designing and implementing technical solutions for market offerings inside your own Offering Portfolio, with a strong emphasis on estimation and pricing. These deals could have any combination of Application Management Services (AMS), Infrastructure Management Services (IMS), Cloud Managed Services (CMS), or Business Process Outsourcing (BPO) across industries. The Operate Solution Hub is designed to drive an optimum process for solutioning and pricing cross-Operating Portfolio/tower operate deals, reducing friction for cross-Offering Portfolio pursuits and optimizing review. By providing services such as inputs for deal qualifications, benchmarks/effort estimation, and solution/pricing review, the Operate Solution Hub will be a focused space to increase win rates and profitability. Key Responsibilities may include: Solution Design and Architecture analysis, business case development, and reviewing pricing model inputs. Assist in creating and refining deal shapes with a focus on pricing strategies and cost optimization. Bring in multi-offering synergies in deal solutioning from the OP perspective, with a particular focus on estimation and pricing integration. When needed, help provide feedback on key contracting terms and Service Level Agreements (SLAs) under the guidance of senior specialists. Contribute to development of estimation frameworks and pricing model frameworks. Client Interaction and Collaboration Help leadership articulate integrated solutions to clients by participating in development of presentations. Embed multi-offering synergies and create value propositions for client requirements, emphasizing estimation and pricing benefits. Support the solution team during client discussions, orals, and due diligence. Internal Coordination Collaborate closely with all stakeholders of the pursuit. Participate in pricing review meetings with internal stakeholders. Work closely with Transition and delivery teams on delivery feedback loops, ensuring pricing strategies are maintained. Collaborate with other industry Subject Matter Experts to come up with business aligned metrics, such as Business Level Agreements (BLAs) and Experience Level Agreements (XLAs), with a focus on pricing efficiency. Qualifications Senior Consultant Education (Undergrad or Masters): MCA, BCA, BE/BTech in CS, IT, or any Business major 6-8 years of experience Focused on quality results (analyses and deliverables) Multi-offering experience with solutioning and commercial models Strong analytical and consulting skills, including experience in supporting business case development and analyzing data to drive decisions Knowledge of AMS/IMS/CMS/BPaas solution tenets and solution integration Written and oral communication skills with the ability to put together cohesive decks Advanced Excel skills Strong expertise in pricing strategies and cost optimization Location: USI How you’ll grow At Deloitte, we’ve invested a great deal to create a rich environment in which our professionals can grow. We provide our professionals with a variety of learning and networking opportunities, some of which are: Intensive trainings on latest technologies from eminent external trainers. Internal trainings and workshops. Subscriptions to prominent online training platforms, such as LinkedIn. Hackathons and tech challenges to exercise your front-end skills. Freedom to adopt and use the latest technologies in your live projects. Travel opportunity (wherever possible) to work at the client’s location or at our global offices. Apart from the above, you will have access to DU: The Leadership Center in India, our state-of-the-art, world-class learning Center in the Hyderabad offices is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Deloitte’s culture Our positive and supportive culture encourages our people to do their best every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer comprehensive well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead happy lives. Learn more about Life at Deloitte. Corporate citizenship Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships that we have with our clients, our people and our communities.We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. #National_Consulting Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 301801 Show more Show less

Job Title: Medical Writer Company : MS Clinical Location : Bangalore Job Type : Full-time Experience: 2-4 years About MS Clinical : MS Clinical is a dynamic and innovative company dedicated to advancing medical research and improving patient outcomes. We specialize in conducting clinical trials and providing comprehensive medical writing services to pharmaceutical, biotechnology, and healthcare organizations worldwide. Job Description : We are seeking an experienced Medical Writer to join our vibrant team. The successful candidate will be responsible for creating high-quality, scientifically accurate medical documents in support of our clinical trial activities and regulatory submissions. The ideal candidate will have a strong background in medical writing, excellent communication skills, and the ability to work both independently and collaboratively in a fast-paced environment. Responsibilities : Prepare and review clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and other clinical trial documents in accordance with regulatory guidelines and industry standards. Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to ensure the accuracy and completeness of medical writing deliverables. Interpret and summarize clinical trial data from various sources, including study reports, statistical analyses, and scientific literature. Assist in the preparation of regulatory submissions, including INDs, NDAs, BLAs, and MAAs, by providing high-quality medical writing support. Participate in project meetings, provide updates on the status of medical writing activities, and contribute to project planning and timelines. Stay current with developments in the field of medical writing, regulatory requirements, and therapeutic areas relevant to our projects. Mentor junior medical writers and provide guidance on best practices for medical writing and document preparation. Qualifications : Bachelor's degree in life sciences, pharmacy, or related field; advanced degree (e.g., MD, PhD, PharmD) preferred. Minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Proficiency in interpreting and summarizing clinical trial data, including statistical analyses and safety reports. Strong understanding of regulatory guidelines (e.g., ICH, FDA, EMA) governing the preparation of clinical trial documents and regulatory submissions. Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts clearly and effectively. Detail-oriented with exceptional organizational and time management skills. Ability to work independently and collaboratively in a multidisciplinary team environment. Proficiency in Microsoft Office Suite and familiarity with document management systems (e.g., SharePoint). Benefits : MS Clinical offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development and advancement. Show more Show less

Description Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Primary Skills required Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH). Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables. Experience with post-approval changes, tech transfers, and product lifecycle management. Excellent written communication, scientific writing, and document organization skills. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars. Secondary Skills required Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics. Qualifications Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences. Ability to work independently and manage multiple priorities in a fast-paced consulting environment. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Description Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Primary Skills required Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH). Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables. Experience with post-approval changes, tech transfers, and product lifecycle management. Excellent written communication, scientific writing, and document organization skills. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars. Secondary Skills Required Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics. Qualifications Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences. Ability to work independently and manage multiple priorities in a fast-paced consulting environment. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Location: This is a remote position based in India , with flexibility for occasional travel as determined by business needs. Note that due to limitations in some internal systems or third-party job platforms, the location may appear as “United States” in certain fields. However, this role is intended to be filled by a candidate located in India . The Opportunity We are seeking a Senior Safety Physician to be located in India who will join our growing Pharmacovigilance team. You will be responsible for the medical evaluation and oversight of safety data across clinical development programs, ensuring compliance with regulatory requirements. The ideal candidate will have a strong foundation in pharmacovigilance and clinical safety, and will be responsible for the analysis, coding, interpretation, and reporting of safety data at Praxis. This position offers the opportunity to work at the intersection of clinical development, regulatory affairs, and medical safety, and includes collaboration with cross-functional teams and external partners. Primary Responsibilities Core member of the Pharmacovigilance (PV) team and Safety Review Board; act as unblinded safety representative for DSMBs. Coordinate and participate in DSMB meetings, including minute-taking, communication, and safety data support. Support signal detection and safety review activities through data preparation, literature review, and maintenance of safety surveillance plans and risk management strategies. Conduct medical review of individual case safety reports (ICSRs), including SAEs, ADRs, and SUSARs. Perform aggregate safety data analysis and contribute to safety reports (e.g., DSURs, PSURs/PBRERs, RMPs). Support safety-related regulatory submissions and responses (e.g., INDs, NDAs, BLAs). Oversee PV vendors to ensure report quality and timely regulatory reporting and ensure timely exchange of safety information; manage PV agreements with business partners. Prepare Health Hazard Evaluations and support clinical trial safety monitoring activities, and review of study protocol, informed consent and investigator brochure. Communicate safety issues to internal stakeholders and regulatory agencies; represent PV in cross-functional teams. Qualifications And Key Success Factors Medical degree (MBBS or MD) from an accredited institution; postgraduate training (e.g., MD, DNB) is strongly preferred. May consider highly qualified Nurse Practitioner, PharmD or allied health professional. At least 3 - 5 years of relevant experience in a pharmacovigilance role within the pharmaceutical or biotechnology industry; minimum of 1 year of clinical trial experience is highly desirable. Experience with regulatory filings and submissions of INDs, NDAs, and MAAs. Knowledge of regulatory and compliance requirements governing pharmacovigilance including FDA, EMA, ICH, and GVP. Experience in individual case safety reporting (clinical trial and post-marketing), aggregate reporting, signal detection, risk management planning, and regulatory inspections. Experience with PV SOP development. Experience with implementation of signal detection tools and safety databases is a plus. Familiarity with coding using MedDRA and the WHO-Drug dictionary. Must possess excellent oral and written English communication skills. Ability to prioritize across complex clinical research studies. Demonstrated strategic and critical thinking skills. Ability to interact externally and internally to support scientific and business strategies. Ability to exercise judgment and address complex problems and find solutions across multiple projects. The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Annualized Base Salary: ₹3,485,000 INR - ₹4,200,000 INR Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust , Ownership , Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. Show more Show less