62 Drug Development Jobs

As a Production Associate at Piramal Pharma Solutions (PPS), you will be part of a dynamic team within a Contract Development and Manufacturing Organization (CDMO) that offers end-to-end solutions across the drug life cycle. Your role will involve contributing to the development and manufacturing processes to ensure the delivery of high-quality pharmaceutical products. In this position, you will work at Piramal Enterprises Limited, located at Plot # 67-70, Sector II, Dhar, Madhya Pradesh, 454775, IN. As a full-time employee, you will be expected to adhere to the job schedule and actively participate in the production activities. The Piramal Group, with a strong foundation of inclusive growth and ethical practices, values equal employment opportunities. Employment decisions are based on merit, taking into consideration qualifications, skills, performance, and achievements. As an organization, we strive to provide equal opportunities to all applicants and employees in various personnel matters, ensuring fairness in recruitment, training, promotion, compensation, and working conditions. PPS offers a wide range of services including drug discovery solutions, process development, clinical trial supplies, commercial API manufacturing, and finished dosage forms. Additionally, specialized services such as highly potent APIs, sterile fill/finish, and biologics manufacturing are also provided. With a global network of facilities, PPS has established itself as a trusted partner for innovators and generic companies worldwide. Join us at Piramal Pharma Solutions and be part of a team that is committed to excellence, innovation, and growth in the pharmaceutical industry.,

As the Vice President of Formulation Development at Symphony Formulations Pvt Ltd, you will play a crucial role in leading the formulation R&D team based in Hyderabad. Your primary responsibilities will include overseeing project management, ensuring timely delivery of product development milestones, and strategic planning to foster innovation in drug formulation processes. You will be required to manage philanthropy initiatives, collaborate with cross-functional teams, and optimize formulation strategies to achieve corporate goals. To excel in this role, you should have a strong background in philanthropy, strategic planning, and project management. Your leadership and team management skills will be essential in guiding the team towards success. Additionally, your advanced knowledge in drug development and formulation processes will be instrumental in driving innovation and problem-solving within the organization. Ideally, you should hold a Master's or Ph.D. in Pharmaceutical Sciences, Chemistry, or a related field. Previous experience in the pharmaceutical industry, especially in formulation development, will be highly beneficial. Your proficiency in budgeting, along with your proactive problem-solving abilities, will enable you to lead the team effectively and contribute to the company's growth and success.,

As a Safety & PV Specialist I at Syneos Health, based in the Pune Office, you will play a crucial role in ensuring the safety and pharmacovigilance of our products. Your primary responsibility will be to enter information into PVG quality and tracking systems for the receipt and tracking of ICSRs. Additionally, you will assist in the processing of ICSRs according to SOPs and project-specific safety plans. In this role, you will triage ICSRs, evaluate the data for completeness and accuracy, and ensure regulatory reportability. You will enter data into the safety database, code events, medical history, concomitant medications, and tests, and compile complete narrative summaries. Your attention to detail will be essential as you identify information to be queried and follow up until all queries are satisfactorily resolved. Moreover, you will be responsible for generating timely and accurate expedited reports in compliance with regulatory requirements. You will maintain safety tracking for assigned activities, perform literature screening and review for safety, drug coding, and MedDRA coding. Your role will also involve validation and submission of xEVMPD product records, management of duplicate ICSRs, activities related to SPOR/IDMP, quality review of ICSRs, and ensuring all relevant documents are submitted to the TMF and Pharmacovigilance System Master File. To excel in this position, you must maintain a thorough understanding and compliance with SOPs, global drug regulations, GCP, ICH guidelines, and project/program plans. Building constructive relationships with internal and external team members, participating in audits, and applying regulatory intelligence to safety reporting activities will be vital components of your role. Syneos Health is committed to developing its employees and providing a supportive and inclusive work environment where you can be your authentic self. Join us in our mission to accelerate customer success and make a meaningful impact on the lives of patients worldwide.,

You will be responsible for leading scientific engagement with Medical Experts as the MSL Manager. In this role, you will implement clinical and educational strategies, as well as respond to unsolicited medical inquiries. Your key responsibilities will include building and maintaining scientific relationships with Medical Experts, identifying key accounts aligned with medical priorities, developing engagement plans tailored to country-specific strategies, and providing accurate scientific information in response to medical inquiries. Additionally, you will support clinical trial execution, facilitate Investigator Initiated Trial processes, act as a scientific resource for internal field teams and partners, and ensure timely reporting of adverse events and product complaints. To excel in this role, you must have proven experience in operations management and cross-functional collaboration, a strong understanding of clinical research and medical affairs processes, proficiency in scientific communication including medical writing and data interpretation, familiarity with CRM tools and digital platforms for stakeholder engagement, knowledge of disease management, drug development, and epidemiology, and the ability to analyze and present clinical data effectively. Fluency in English, both written and spoken, is essential. Desirable requirements include prior experience in a Medical Scientific Liaison or similar field-based medical role, as well as an advanced degree in life sciences such as MD, PhD, or PharmD. Novartis is committed to creating an inclusive work environment and diverse teams that represent the patients and communities served. If you require any reasonable accommodation due to a medical condition or disability during the recruitment process, please reach out to [email protected] with the details of your request and the job requisition number. Join Novartis in reimagining medicine to improve and extend people's lives. Be part of a community of smart, passionate individuals collaborating, supporting, and inspiring each other to achieve breakthroughs that positively impact patients" lives. Visit https://www.novartis.com/about/strategy/people-and-culture to learn more about our mission and opportunities.,

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may independently provide timely and professional leadership of special projects that focus on innovative tools and systems. You will strategically and tactically support the Director Clinical Data Standards and be responsible for advising/leading the planning, development, and implementation of Industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. Your role will also involve providing expert support and stellar customer focus to business users and teams on their use of data standard collection tools, data transfer specifications, analysis data/TFL standards/Define, automation solutions/technologies, and business infrastructure, business rules, and guidelines. You may also lead global teams as required. At the study level, you will be responsible for all statistical tasks on assigned clinical or non-clinical trials, particularly for high complexity trials, seeking peer input/review as required. You will contribute to protocol development, statistical analysis plan development, and reporting activities. Additionally, you will provide statistical expertise to support submission activities and documents, meetings with Health Authorities, pricing agencies, and other drug development activities. You will independently lead interactions with external review boards/ethics committees, external consultants, and represent the organization in statistical discussions at external congresses, conferences, and scientific meetings. You will be responsible for strategic statistical input into one or more projects, collaborating with clinical, regulatory, and other strategic functions to drive quantitative decision-making in drug development. At the disease area/TA/indication level, you will drive strategic statistical input and excellence to development programs within the assigned areas. Additionally, you may lead or significantly contribute to initiatives at the global line function level or cross-functional franchise level, requiring coordination of diverse team members. You will actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives and represent the organization in due diligence teams for in-licensing opportunities. The ideal candidate will have an MS (in Statistics or equivalent) with 10+ years of relevant work experience or a PhD with 6+ years of relevant work experience. Strong interpersonal and communication skills, along with proven expertise in statistics and its application to clinical trials, are essential. Additionally, experience with statistical software packages such as SAS or R, and a strong understanding of drug development and Health Authority guidelines are required. The role may also require expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Novartis is committed to providing reasonable accommodation to individuals with disabilities. For more information or to request accommodation during the recruitment process, please contact [email protected] and include the job requisition number in your message.,

The position of Global Medical Advisor in the Medical Affairs department at Novo Nordisk involves providing strategic and medical guidance for a portfolio of products. As a part of the APAC Medical Affairs team, you will play a crucial role in various aspects such as the PDP process, interpretation and communication of scientific data, and understanding the clinical importance of new findings related to diabetes, obesity, rare diseases, and OSCD. Your responsibilities will include acting as the PDP Secretary, driving the PDP process at the regional level, and ensuring the timely and accurate delivery of scientific medical guidance to internal and external stakeholders. You will also be responsible for managing effective collaboration within the APAC medical affairs team, acting as a liaison between Novo Nordisk and Key Opinion Leaders, and ensuring the application of Novo Nordisk policies and procedures. Additionally, you will be involved in developing and maintaining relationships with Global Key Opinion Leaders, planning and executing meetings, supporting speakers in presenting data at conferences, and engaging in scientific dialogue to advance the company's products. Your role will also entail providing medical guidance, developing medical documents and digital solutions, and supporting key markets and affiliates through training and education. The ideal candidate for this position should hold an M.D. with substantial clinical and/or research expertise in relevant areas such as Endocrinology, Cardiology, General Practice, or Internal Medicine. Strong clinical and/or research background in diabetes mellitus, experience in drug development, and fluency in English are essential qualifications. Demonstrated research experience, at least 2 years of clinical and/or pharmaceutical industry experience, and familiarity with clinical research and development are also required. Joining the Global Medical Affairs team at Novo Nordisk in Bangalore means becoming part of a motivated group of global scientific advisors, project managers, and publication managers working together to communicate scientific and medical knowledge on company products. As a leading global healthcare company dedicated to defeating serious chronic diseases, Novo Nordisk offers a collaborative and inclusive work environment where employees are encouraged to bring their unique skills and perspectives to the table. If you are passionate about making a difference and contributing to life-changing initiatives, we invite you to apply by submitting your CV and motivational letter online before the deadline of 28th February 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants, and we do not extend unsolicited employment offers or charge fees to prospective employees. Our goal is to be the best company for the world, and we believe that diversity and inclusion are essential to achieving this vision. Together, we are life changing.,

You will be responsible for providing Project Portfolio reports to facilitate decision-making and prioritize the project portfolio. You will own the cross-functional project plans within the Project Management tools, ensuring proper project management and oversight by major stakeholders. This includes creating portfolio reports with necessary information such as resource forecasts and historical portfolio trends. Additionally, you will oversee and review resource forecasting for the project portfolio, maintaining accurate and up-to-date information and establishing governance processes for monitoring forecast accuracy. You will also be accountable for developing and implementing project plans in the Development Project Management tools along with the line function team. Furthermore, you will be required to enhance and develop tools as per the needs of project management and other stakeholders. Your main focus will be on optimizing resources and productivity, ensuring timely and well-informed project decisions, and gathering feedback from customers, partners, and projects to enhance satisfaction levels. It is essential to adhere to Novartis policies and guidelines. The ideal candidate should have work experience that demonstrates functional breadth, critical negotiations, collaborating across boundaries, operations management and execution, and project management skills. Additionally, proficiency in account management, building construction, business administration, business relationship management, capital market, corporate development, cross-functional collaboration, drug development, financial modeling, innovative forward thinking, investment portfolio, IT portfolio management, mergers & acquisitions, operations, pipeline software, PMP certification, portfolio analysis, prioritization, senior management, and virtual private server management is required. Proficiency in the English language is necessary for this role.,

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams Take your career farther than you thought possible, Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more: careers bms /working-with-us , Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications ( e-g ADaM specifications) Reviews key planning documents ( e-g , statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure ( e-g CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications ( e-g MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data ( e-g multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, ( e-g ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career, Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science?, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues, On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function, BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms Visit careers bms / eeo -accessibility to access our complete Equal Employment Opportunity statement, BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters, BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area, If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers bms /california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations, Show

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams Take your career farther than you thought possible, Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more: careers bms /working-with-us , Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications ( e-g ADaM specifications) Reviews key planning documents ( e-g , statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure ( e-g CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications ( e-g MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data ( e-g multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, ( e-g ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members, Preferred Requirements: Management experience supervising technical professionals, If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career, Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science?, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues, On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function, BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms Visit careers bms / eeo -accessibility to access our complete Equal Employment Opportunity statement, BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters, BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area, If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers bms /california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations, Show

About ValGenesis: ValGenesis is a leading digital validation platform provider for life sciences companies. The ValGenesis suite of products is utilized by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance, and manufacturing excellence across their product lifecycle. About the Role: As a Junior Validation Engineer at ValGenesis, you will work as a team member in the Validation department. Your primary responsibility will be to validate all product releases. Requirements: - A BE/BS degree in Biomedical, Pharmaceutics, or a related field. - Knowledgeable about the product development life cycle. - Familiar with drug development and manufacturing processes. - Self-motivated and eager to learn new concepts, technologies, and products quickly. - Possess excellent interpersonal, writing, and communication skills, as well as troubleshooting abilities. - Passionate about testing, validation, and product quality. Responsibilities: As a Junior Validation Engineer, you will: - Engage in hands-on work individually to deliver on project requirements. - Collaborate with Product, Engineering, and Testing teams to understand product functions. - Review various product requirements, including Epics, User stories, User Requirements, Software Requirements, etc. - Develop test cases in OQ and PQ protocols in alignment with requirements and Quality Management System (QMS) guidelines. - Create realistic test cases and test data based on customer usage scenarios. - Execute test cases, document defects, deviations, and report test results. - Participate in peer reviews of test cases, test data, and test designs. - Work in a highly collaborative team environment with effective communication among team members. - Maintain a good understanding of the company's QMS standards. - Author documents in accordance with QMS guidelines. Mission Statement: In 2005, ValGenesis disrupted the life sciences industry by introducing the world's first digital validation lifecycle management system. ValGenesis VLMS revolutionized compliance-based corporate validation activities and set the industry standard. Today, we continue to innovate and expand our portfolio beyond validation with an end-to-end digital transformation platform to meet evolving regulations and quality expectations in the life sciences industry. Joining the Team: At ValGenesis, customer success is paramount. We prioritize the customer experience in all aspects, from product development to marketing, sales, services, and support. We work collaboratively, communicate openly, support each other, and embrace innovation. Our goal is to become the leading intelligent validation platform in the market. Work Environment: Our Chennai, Hyderabad, and Bangalore offices operate onsite, five days a week. We believe that in-person interaction and collaboration are essential for fostering creativity, building a sense of community, and driving our future success as a company.,

The candidate will undergo a self-financed job-oriented patent analyst training at the Indian Institute of Patent and Trademark. On successful completion of the training, they will be placed for full-time patent analysis in the pharmaceutical domain. Required Candidate profile Scientific and Analytical Thinking Eager to work in drugs and formulation Candidates must have sound knowledge about the subjects they study in Graduation

You will be responsible for leading the out-licensing efforts for the pharmaceutical pipeline of the company. As a skilled Business Development Professional, your main tasks will include identifying global partners, driving licensing strategies, leading deal negotiations, and collaborating with cross-functional teams. To excel in this role, you should possess a strong grasp of drug development, regulatory requirements such as US FDA, EMA, and intellectual property matters. Experience with licensing deals in regulated markets like the US, EU, and Japan will be highly beneficial. Your key attributes should include excellent negotiation skills, analytical capabilities, and effective stakeholder management. As the ideal candidate, you should hold a Master's degree in Pharmacy or Life Sciences, with an MBA being preferred. This position is based in Hyderabad and will report to the Head of Business Development & Portfolio. With at least 8 years of experience in pharmaceutical business development and out-licensing, you will play a crucial role in expanding the company's global partnerships and driving its growth in the pharmaceutical industry.,

You will be responsible for leading the out-licensing efforts for our pharmaceutical pipeline as a skilled Business Development Professional. The location for this role is Hyderabad (Onsite) and you will report to the Head of Business Development & Portfolio. To be successful in this position, you should have at least 5-8 years of experience in pharma business development and out-licensing. Your main responsibilities will include identifying global partners, driving licensing strategies, leading deal negotiations, and collaborating with cross-functional teams. It is essential to have a strong understanding of drug development, regulatory processes (such as US FDA, EMA), and intellectual property rights. Experience with licensing deals in regulated markets such as US, EU, and Japan will be highly beneficial. In addition, you should possess excellent negotiation skills, analytical abilities, and stakeholder management skills to excel in this role. A Master's degree in pharmacy or Life Sciences is required for this position, with an MBA being preferred.,

As a Site Contracting Team Lead (SCTL) at Pfizer, you will be responsible for planning and achieving contract execution targets, managing risks to APAC targets, and collaborating with other functional lines and planners to effectively plan, prioritize, and allocate resources for studies within your remit. In this role, you will provide expertise and support to your team and other site contracting professionals, helping them independently resolve issues related to site contracting and cross-functional dependencies. Additionally, you will partner with other countries to optimize portfolio support, manage country and study level issues within your scope, and support regional site contracting needs through process updates and master agreement negotiations. Your key responsibilities will include resolving site contracting impacts on quality or timelines through risk analysis, leading reviews of your team's contracts, aligning with other team leads on portfolio forecasting, providing timely solutions for global contract negotiation issues, analyzing study reports to keep site contracts off the critical path, suggesting new contracting approaches to minimize cycle times, serving as the site contracting subject matter expert on group projects, and supporting Regional Head, Site Contracting in onboarding, training, and managing ICLs and contractors within assigned countries. To excel in this role, you should have 10+ years of experience with a 4-year degree, expertise in clinical site contracting, knowledge of the clinical development process, ability to oversee third-party vendor deliverables, experience leading cross-functional teams, interaction with senior leaders, proficiency in clinical study budgets and contracting negotiation, a balance of business, compliance, finance, legal, and drug development experience, clear communication and presentation skills, problem-solving capabilities, demonstrated leadership and team development skills, and experience in a matrix-based organization. Preferred qualifications include 7+ years of relevant experience with a US Juris Doctorate or equivalent legal degree and previous functional management experience. This position offers a remote work location assignment. Pfizer is an equal opportunity employer that complies with all applicable equal employment opportunity legislation in each jurisdiction where it operates. Join us in Global Procurement and make a difference in the world of healthcare.,

You will be responsible for designing, planning, performing, interpreting, and reporting the results of scientific experiments to prepare and deliver drug substances, drug products, and processes within a multifunctional project team led by a Project Leader. You will manage technical laboratory and plant activities. As a part of the Management Track, you will lead a team in developing pharmaceutical, biological, or cell-gene therapies in a small manufacturing plant environment. You will execute the functional strategy, drive operational excellence in line with TRD vision and strategy, and ensure full portfolio support in alignment with GDD, Sandoz, NTO, and NIBR plans. In the role of an Associate Scientist, you will design, plan, perform, interpret, and report scientific experiments for the development and timely delivery of drug products within a project team. Additionally, you will manage technical lab and plant activities. As a Scientist, you will be responsible for designing, planning, performing, and interpreting scientific experiments for the development and timely delivery of drug products. You will lead and manage project activities, support team members, contribute to overall strategies and goals. In the position of a Senior Scientist, you will design, plan, perform, document, and interpret scientific experiments and GMP testing or pilot plant processes for generic products. You will maintain equipment, manage operational aspects in the lab or plant, and ensure timely delivery. Key Responsibilities: - Meet quality, quantity, and timeline goals in all projects while aligning with the overall drug development process. - Plan, organize, perform, and document scientific experiments in collaboration with project teams under minimal guidance. - Provide efficient processes for specialized facilities and manufacturing operations. - Document raw data, evaluate results, propose next experiments, and optimize methods and workflows. - Generate lab procedures, reports, instructions, and SOPs, and transfer procedures to production. - Communicate problems, conduct safety searches, manage chemicals, and collaborate with team members. - Evaluate new equipment, contribute to maintenance, and ensure adherence to quality and compliance standards. - Support resource planning, quality mindset, and training compliance. - Adhere to HSE rules and guidelines, contribute to increasing efficiency, and provide measurable contributions to projects. Minimum Requirements: - B. Pharm /M. Pharm with 3-8 years of relevant experience. - Experience in safe handling of chemicals and equipment, working in interdisciplinary teams, and knowledge of SOPs and GMP regulations. - Proficiency in scientific/technical areas, laboratory tools, software, and communication skills. Join Novartis to be part of a community dedicated to helping people with diseases and their families. Collaborate, support, and inspire breakthroughs that change patients" lives. Ready to create a brighter future together ,

Novo Nordisk Global Business Services (GBS) India Department Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Senior Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. About the department Bangalore Global Development since its inception, has transitioned from a small start-up to one of the largest units in Global Business Services, Bangalore (GBS) and a key contributor to Novo Nordisk clinical development portfolio. The Centralised Monitoring Unit (CMU) was established in GBS in 2016 to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is the single and only entity across the globe responsible for performance of centralised medical monitoring for all clinical trials involving medical review of patient data that includes medical monitoring and lab surveillance and generation of visualisations and reports identifying outliers and trends from various data sources. The Position As a Senior Functional Programmer, the role involves generating standard and customized trial monitoring reports to support Risk-Based Quality Monitoring (RBQM) across clinical trial portfolios, using tools like SQL, SAS, Power BI, and Python. Responsibilities include understanding stakeholder needs, programming data-driven reports from multiple clinical systems, and ensuring high-quality deliverables through rigorous quality checks. The role also includes preparing documentation, supporting process improvements, and contributing to training initiatives. Responsible to generate standard and custom trial monitoring reports using languages like SQL, SAS, Python in different BI tools (Qlik Sense, Power BI, SAS JMP Clinical, Clue Point, eClincal etc.) ensuring alignment with stakeholder needs and RBQM requirements. Responsible to prepare, maintain, and peer-review report-related documentation; develop and perform quality checks to ensure accuracy and compliance. Conduct and chair trial monitoring meetings, gather requirements, train stakeholders on report usage, track requests, and manage expectations and timelines. Train and mentor new team members, support onboarding processes, and assist in developing training materials based on project needs. Ensure contributing to process enhancements, share best practices, and support the manager in resource allocation and project timeline planning. Qualifications A Masters or Bachelors degree in Life Sciences, Computer Science, Information Technology, Clinical Information Management, or a related field. Equivalent qualifications or relevant professional certifications will also be considered. 4"“6 years of experience in the pharmaceutical or life sciences industry, with a minimum of 4 years in clinical data management systems, bioinformatics, or as a Clinical Research Associate. Strong technical proficiency in computer systems and IT, particularly as they apply to clinical data handling and process optimization. In-depth understanding of GxP principles, as well as international guidelines and regulations related to drug development. Knowledge of computer system validation practices is essential. Proven experience in project management, team supervision, and mentoring, with the ability to lead cross-functional and cross-regional collaborations effectively. Strong interpersonal and presentation skills, with the ability to communicate complex technical and clinical concepts to both technical and non-technical stakeholders. Solid understanding of the drug development lifecycle, along with working knowledge of basic medical and clinical terminology. Advanced skills in any of the programming languages such as SAS, VBScript, SQL, PL/SQL, Power BI, or Python. Experience with additional tools like JSL, R-Shiny, or Natural Language Processing (NLP) is a strong plus.

Novo Nordisk Global Business Services (GBS) India Department Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. About the department Bangalore Global Development since its inception, has transitioned from a small start-up to one of the largest units in Global Business Services, Bangalore (GBS) and a key contributor to Novo Nordisk clinical development portfolio. The Centralised Monitoring Unit (CMU) was established in GBS in 2016 to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is the single and only entity across the globe responsible for performance of centralised medical monitoring for all clinical trials involving medical review of patient data that includes medical monitoring and lab surveillance and generation of visualisations and reports identifying outliers and trends from various data sources. The Position As a Functional Programmer, the role involves generating standard and customized trial monitoring reports to support Risk-Based Quality Monitoring (RBQM) across clinical trial portfolios, using tools like SQL, SAS, Power BI, and Python. Responsibilities include understanding stakeholder needs, programming data-driven reports from multiple clinical systems, and ensuring high-quality deliverables through rigorous quality checks. The role also includes preparing documentation, supporting process improvements, and contributing to training initiatives. Responsible to generate standard and custom trial monitoring reports using languages like SQL, SAS, Python in different BI tools (Qlik Sense, Power BI, SAS JMP Clinical, Clue Point, eClincal etc.) ensuring alignment with stakeholder needs and RBQM requirements. Responsible to prepare, maintain, and peer-review report-related documentation; develop and perform quality checks to ensure accuracy and compliance. Conduct and chair trial monitoring meetings, gather requirements, train stakeholders on report usage, track requests, and manage expectations and timelines. Train and mentor new team members, support onboarding processes, and assist in developing training materials based on project needs. Ensure contributing to process enhancements, share best practices, and support the manager in resource allocation and project timeline planning. Qualifications A Masters or Bachelors degree in Life Sciences, Computer Science, Information Technology, Clinical Information Management, or a related field. Equivalent qualifications or relevant professional certifications will also be considered. Above 3 years of experience in the pharmaceutical or life sciences industry, with a minimum of 2 years in clinical data management systems, bioinformatics, or as a Clinical Research Associate. Strong technical proficiency in computer systems and IT, particularly as they apply to clinical data handling and process optimization. In-depth understanding of GxP principles, as well as international guidelines and regulations related to drug development. Knowledge of computer system validation practices is essential. Proven experience in project management, team supervision, and mentoring, with the ability to lead cross-functional and cross-regional collaborations effectively. Strong interpersonal and presentation skills, with the ability to communicate complex technical and clinical concepts to both technical and non-technical stakeholders. Solid understanding of the drug development lifecycle, along with working knowledge of basic medical and clinical terminology. Advanced skills in any of the programming languages such as SAS, VBScript, SQL, PL/SQL, Power BI, or Python. Experience with additional tools like JSL, R-Shiny, or Natural Language Processing (NLP) is a strong plus.

The Global Safety Therapeutic Areas at Amgen serve as the safety experts for all Amgen products globally. They are responsible for defining the safety strategy and major safety deliverables for each Amgen product. As a leader in the therapeutic area safety teams, you will oversee staff management and resource allocations in Global Patient Safety. Your role will involve supporting GPS in establishing a highly effective global safety organization that complies with worldwide regulations. As a Global PV Sr. Scientist, you will collaborate with the Therapeutic Safety Teams on safety assessment activities related to medical and scientific operations. Additionally, you will provide scientific and compliance expertise to GPS as required. Your responsibilities as a Global PV Sr. Scientist include directing the planning, preparation, writing, and review of portions of aggregate reports. You will also coordinate liaison activities with affiliates and other internal partners at Amgen regarding products. Furthermore, you will provide oversight to staff on safety in clinical trials, review study protocols, statistical analysis plans, clinical study-related documents, adverse events, and safety data from clinical studies. You will be involved in signal detection, evaluation, and management, performing data analysis for safety signals, documenting work in the safety information management system, authoring Safety Assessment Reports, and collaborating with the GSO on safety documents and regulatory responses. Additionally, you will support risk management activities, prepare responses to regulatory inquiries, and contribute to new drug applications and other regulatory filings. In terms of inspection readiness, you will undertake activities delegated by the QPPV as outlined in the PV System Master File and maintain a state of inspection readiness. You will also serve as a representative and point of contact for Health Authority Inspections and Internal Process Audits within your role and responsibility. Your knowledge and skills should encompass a range of areas including pharmacovigilance regulations, drug development, safety data capture, safety database structure, MedDRA, safety data analysis, risk management, and product knowledge. You should also possess intermediate skills in various pharmacovigilance processes, document writing, risk management plans, statistical methods, biomedical literature review, organization, collaboration, critical assessment, scientific writing, and communication. A strong background in pharmacovigilance, expertise in defined subject areas, problem-solving abilities, autonomy in executing strategies, and a contribution to business results through quality and leadership are essential. Your education should include a Doctorate/Masters degree/Bachelors degree with 12 to 17 years of directly related experience, preferably in Life Sciences with managerial experience and clinical/medical research expertise in a biotech/pharmaceutical/CRO setting.,

As the Regulatory Affairs Manager at Natural Biogenex Pvt. Ltd. (NBPL), you will be responsible for overseeing the regulatory submission processes, ensuring compliance with all applicable regulations, and managing the regulatory strategy for pharmaceutical products. Your role will involve working closely with various departments such as R&D, Quality Assurance, and Marketing to facilitate the development and commercialization of pharmaceutical products. Your key responsibilities will include developing and implementing regulatory strategies for drug development and approval, guiding regulatory requirements and compliance to internal teams, preparing and submitting regulatory documents to health authorities, managing communication with regulatory authorities, monitoring changes in regulations to ensure compliance, working collaboratively with cross-functional teams, managing multiple regulatory projects simultaneously, and maintaining accurate records of regulatory submissions and communications. To excel in this role, you should possess a Bachelor's or Master's degree in pharmacy, along with a minimum of 12 - 15 years of experience in regulatory affairs within the pharmaceutical industry for filing products in various regulatory agencies. You should have a strong understanding of regulatory guidelines and compliance requirements (such as FDA, EMA, etc.), excellent communication, organizational, and project management skills, and the ability to work collaboratively in a fast-paced environment. By joining Natural Biogenex Pvt. Ltd., you will have the opportunity to be a part of a leading API manufacturing company with cutting-edge technology and compliance standards. You will work in a state-of-the-art Quality Control Laboratory with global regulatory standards, contribute to regulatory audits and pharmaceutical quality excellence, and benefit from competitive salary and professional development opportunities.,

The Medical Expert in TCO (Translational Clinical Oncology) serves as the medical leader for assigned global, roll-over, and long-term follow-up studies, as well as studies in the close-out phase. Additionally, they may provide medical co-leadership for assigned aspects of global, active TCO studies under the guidance of a Clinical Program Leader (CPL). TCO, a department under the Biomedical Research division, is responsible for designing and conducting early-phase clinical studies in cancer patients, acting as a connection between drug discovery and late-phase clinical development to deliver innovative medicines for oncology conditions. Responsibilities include providing medical support to the CPL, contributing to clinical sections of protocols, Informed Consents, publications, regulatory documents, and reviewing clinical trial data. The Medical Expert may also oversee program safety reporting, represent the CPL at project team meetings and Investigator teleconferences, and lead the review of TCO submission documents. Furthermore, they are responsible for managing close-out, roll-over, and long-term follow-up studies, ensuring the quality of clinical study reports, and engaging with stakeholders internally and externally. The Medical Expert mentors junior team members, maintains expertise in regulations and procedures, and advocates for continuous improvement of quality. Key performance indicators include managing studies within timelines and regulatory standards, demonstrating strong scientific writing skills, providing quality medical review of trial data, contributing to department objectives, and receiving positive feedback from stakeholders. The role requires adherence to Novartis Values and Behaviors. Minimum Requirements: - MD or equivalent medical degree with clinical training and certification - At least 5 years of pharmaceutical industry experience - At least 2 years of clinical practice experience - Experience in hematology/oncology preferred - Knowledge of GCP and oncology clinical trials - Strong project management, communication, and interpersonal skills - Ability to work independently and in a team, adapt to changing environments, and network effectively Skills: - Clinical Monitoring - Clinical Research - Clinical Trial Protocol - Decision Making Skills - Drug Development - Health Sciences - Life sciences - Medical Strategy - Regulatory Compliance Language: - English Novartis offers a collaborative environment where passionate individuals can work together to achieve breakthroughs that positively impact patients" lives. For those interested in joining the Novartis Network, opportunities can be explored through the talent community to stay connected with suitable career options. Additionally, Novartis provides benefits and rewards to support personal and professional growth. Novartis is dedicated to fostering an inclusive work environment that represents the diversity of the patients and communities served. Accommodations for individuals with disabilities are available upon request to ensure equal opportunities during the recruitment process or job performance.,

Key Tasks & Responsibilities: The IRT Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinical study protocol with particular focus on the attributes of study drugs including comparators, medical devices, randomization and blinding. Ensures appropriate supply of study medication for all patients in a clinical trial by implementing optimal IRT supply strategies. The Manager continues to assume accountability of the IRT during the systems life cycle, implementing all required amendments. Leads the IRT cross-functional sub-team and is accountable for the set-up and maintenance of the IRT System with special attention to the proper and correct supply of study sites with study medication, including the correct drug dispensation according to the study protocol. Responsible for providing guidance and training to study teams. Qualifications & Competencies: Bachelors Degree or equivalent. Pharmacist degree preferred 5 to 8 years of relevant healthcare clinical development experience Profound knowledge in drug development Profound knowledge in setting up Interactive Response (IRT) Systems Profound knowledge in GCP and knowledge of GMP Excellent project management skills Excellent communication skills (including fluent English).

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: Emerging one stop partner for Complex & CMC R&D for Formulation & API for USA market Position: Asst. Manager - Projects Management Markets: USA Products: Formulations Location: Navi Mumbai Job Profile: Lead cross-functional teams to deliver on project objectives across the product lifecycle (R&D, clinical and commercialization). Develop and maintain comprehensive project plans, including timelines, budgets, resource allocation, risk assessments, and status reports. Serve as the primary point of contact for project stakeholders, ensuring effective communication and alignment. Track project milestones and deliverables; proactively manage risks and resolve issues that arise. Coordinate with regulatory, clinical, manufacturing, and quality teams to ensure projects comply with industry standards (FDA, EMA, ICH, GMP). Support governance and decision-making processes by preparing project updates, dashboards, and presentations for leadership and steering committees. Manage project documentation, including charters, meeting minutes, etc. Strong knowledge of drug development processes, clinical trial phases, regulatory requirements, or GMP manufacturing (based on department). Excellent organizational, interpersonal, and problem-solving skills. Ability to work collaboratively in a fast-paced, matrixed environment. Desired Profile: B.Pharm / B.Sc / M.Sc + MBA (Pharmaceuticals / Healthcare) with 3 to 8 yrs experience in Projects Management with well-known Pharmaceuticals CRO / Pharma R&D Centre. Knowledge of pharmaceutical / biotech industry landscape and recent R&D + Commercial trends. Professional qualification in Project Management. Familiarity with USA pharmaceutical regulation. Strong knowledge of drug development processes, clinical trial phases, regulatory requirements, or GMP manufacturing (based on department). Familiarity with project management tools and methodologies. Demonstrated project management skills. Must be able to facilitate discussions and bring about consensus between all stakeholders. Excellent communication and stakeholder management abilities. Must be able to define project acceptance and success criterion. Must be able to use project management tools. High Degree of numeracy and proficiency in conducting financial analyses. High-level of IT literacy, MS Office applications. Excellent organizational, interpersonal, and problem-solving skills. Ability to work collaboratively in a fast-paced, matrixes environment. Effective negotiation and persuasion skills. Expert planning and organizational skills. Recruiter Details: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722052906, 09722042906 E-Mail: career@bfrr.in Website: www.bestfitrecruitment.co.in

Are you a medical graduate or post-graduate with a passion for research If the clinical challenges excite you and you are eager to delve into new knowledge about health and diseases, including the discovery of rare diseases, then this Ph.D. opportunity might be the perfect fit for you. The Clinical Research Training Programme (CRTP) for rare diseases is designed to equip physicians with the necessary skills to navigate the complex landscape of rare genetic diseases. These diseases often lack effective treatments and impose a heavy burden on patients and their families. By participating in this program, you will have the chance to earn a Ph.D. degree upon completion and become a multi-domain expert capable of bridging the gap between patient care and cutting-edge research in the field of rare genetic diseases. Eligible candidates include post-graduates and graduates in Medical or Dental Sciences with qualifications such as DM, MCh, MD, MS, MBBS, or their equivalents. This program is a collaborative effort between Manipal Academy of Higher Education, Manipal, Institute of Bioinformatics, Bengaluru, and Dr. Reddys Institute of Life Sciences, Hyderabad. It is supported by funding from the DBT Wellcome Trust India Alliance. The program spans 3-4 years and offers comprehensive training in basic science research for physicians. You will gain hands-on experience in various research techniques such as handling samples, sequencing, data analysis, molecular biology, cell culture, animal models, systems biology, and exposure to drug development in both clinical and laboratory settings. The first year of training will take place at MAHE, Manipal, followed by training at MAHE or other participating institutions, with opportunities for international training with collaborators abroad. Mentorship will be provided by approved Ph.D. guides from MAHE, Institute of Bioinformatics, and Dr. Reddys Institute of Life Sciences. Additionally, students will have the chance to learn from international collaborators at renowned institutions around the world. Each candidate will receive a budget of Rs. 50,00,000 to cover salaries, research expenses, and travel. There are six fellowships available, and successful candidates may have the opportunity for permanent positions at the host institution upon completion of the program. To apply, interested candidates can submit their CV and a statement of interest explaining their passion for research and the program to jobs.research@manipal.edu. Join us on this exciting journey to explore the world of rare diseases and make a meaningful impact on healthcare and research!,

As a Project Manager in the pharmaceutical industry with a PhD (Doctor of Philosophy), your role involves overseeing and managing projects related to drug development, clinical trials, regulatory compliance, or other pharmaceutical initiatives Your advanced academic background in pharmaceutical sciences provides you with a deep understanding of the industry and scientific principles You develop project plans, timelines, and budgets, considering the specific objectives, deliverables, and resource requirements of pharmaceutical projects You coordinate with cross-functional teams and stakeholders to ensure effective project execution Risk Assessment and Management: You identify potential risks and challenges associated with the project and develop risk management strategies to mitigate them This includes monitoring and evaluating risks throughout the project lifecycle and implementing contingency plans when necessary Regulatory Compliance: You ensure that projects comply with relevant pharmaceutical regulations, guidelines, and quality standards This may involve coordinating with regulatory affairs teams to obtain necessary approvals, managing documentation for regulatory submissions, and ensuring adherence to Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP) guidelines

4-5 years of experience in project management and alliance management roles in a Generics Pharma organization, including interaction with existing customers to ensure proper supply of products and timely project deliverables. Strong understanding of drug development processes, regulatory requirements, and product lifecycle management, with the ability to review technical data, identify risks, and drive data-based solutions for project challenges. Knowledge of the life cycle of Generic ANDAs from R&D through Commercialization, with past industry exposure in tech transfer requirements, divestitures, BE clinical studies, Regulatory, Legal IP, and Operations. Ability to plan, execute, and monitor pharma projects by aligning cross-functional teams towards timely and cost-effective delivery. Efficient in managing internal teams, external partners, and clients to ensure seamless project coordination. Maintain strong relationships with existing customers through regular communication, periodic review meetings, and proactive issue resolution. Ability to establish and maintain key relationships with external and internal business leaders. Strong communication skills, both written and verbal. Business Development support and being the face of Piramal to marketing and strategic commercial partners. Work closely with Sales and Launch teams from partner firms. Provide leadership to the ex-US licensing initiative and leverage Agile Generic offerings in territories outside the US with strategic partners. Work closely with site heads, functional groups, and colleagues at Piramal Sellersville, Lexington, Pithampur, Morpeth, Hyderabad, and Digwal sites to get buy-in and prioritization for Agile programs. Qualifications Bachelors degree in a scientific subject. MBA in Pharmaceutics, Marketing or Finance preferred. Requirements include being familiar with the ANDA drug cycle process and Generics Pharma industry.