223 Fda Jobs - Page 5

: Job Title Regulatory Filtering Analyst LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certificates and authorization required by governmental agencies Coordinating government interactions and compliance activities; and interacts with regulatory agencies What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory and reputational risk with regard to business involving sanctioned entities and / or countries. Ensure diligent review and confirmation of transactions that require escalation to a Level 2 investigator and decide on these in full compliance with the applicable Sanctions regulations and the banks policies and procedures. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Convert timely the update of the relevant embargo lists in respective filtering systems implement the data to central and decentralized tools in GT and Operations. Support CoC Regulatory Filtering team on the adoption of new clients Your Key Accountabilities RTB focus Primarily review stopped messages and take a decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Record rationale for decision from pre-defined set of options. Seek feedback from more senior investigators/reviewers, where their decisions fail the four-eye control. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorised purposes; actively safeguard sensitive and confidential information. CTB focus Supports TSMO / AFC related change projects Supports remediation actions owned by TSMO / AFC Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How well support you

Lead and manage the QA/QC function at the plant level. Ensure compliance with FSSAI, HACCP, ISO 22000, and other relevant food safety and quality standards. Implement and maintain plant-level SOPs, SSOPs, GMP, and hygiene practices. Accessible workspace

Knowledge and Skills Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System.

We are seeking a skilled and hands-on Embedded Systems Architect to lead the design and development of embedded hardware and firmware systems, spanning microcontroller and microprocessor-based solutions. The ideal candidate will have at least 10 years of experience in embedded systems development, particularly in medical devices or other highly regulated industries. This role will be instrumental in designing high-reliability embedded architectures, ensuring compliance with medical device standards (IEC 62304, ISO 13485, FDA 21 CFR Part 820), and guiding development teams through full product lifecycles. Responsibilities: Architect and oversee development of embedded systems that use 32-bit microcontrollers (STM32, NXP, TI) and application processors (ARM Cortex-A, i.MX, etc.). Drive the complete product life-cycleconcept, requirements capture, architecture, design, implementation, verification, release, and long-term maintenance. Collaborate with hardware, software, quality, and regulatory teams to translate product requirements and constraints into robust system architectures. Lead firmware development in C and C++ for bare-metal, RTOS, and embedded-Linux targets, including board support packages, bootloaders, and secure update mechanisms. Define board-level hardware architecture—power, sensing, and communication subsystems (UART, SPI, IC, CAN, USB, BLE, Wi-Fi, cellular)—in partnership with hardware engineers. Perform system bring-up, low-level debugging, and integration of BSPs, device drivers, and middleware. Ensure compliance with FDA regulations, ISO 13485, IEC 62304, and cybersecurity guidance (AAMI TIR57, FDA Premarket Cybersecurity). Lead risk-management activities, including hazard analysis, FMEA, and verification / validation planning and execution. Evaluate and recommend embedded platforms, SoCs, and communication protocols that best meet technical, cost, and schedule objectives. Conduct design and code reviews, establish best practices, and mentor junior engineers. Produce and maintain high-quality documentation: system architecture specifications, design rationales, test protocols, and risk analyses. Qualifications: 10+ years of hands-on experience in embedded systems development, preferably in regulated industries such as medical devices, aerospace, automotive, or industrial safety. Proficient in C and C++ for real-time, safety-critical, and low-level systems. Deep expertise in embedded Linux development, including Yocto, Buildroot, kernel customization, and driver integration. Strong experience with RTOS (e.g., FreeRTOS, Zephyr, QNX) and bare-metal firmware. Proven background in technical consulting or client-facing product development roles. Solid understanding of ARM Cortex-M/A architectures, embedded security, and peripheral interfaces. Skilled in using debugging and diagnostic tools such as oscilloscopes, logic analyzers, and JTAG/SWD debuggers. Familiar with relevant standards and regulatory frameworks, including IEC 62304, ISO 14971, and FDA software validation. Experience with wireless protocols (BLE, Wi-Fi, LoRa) and embedded cybersecurity practices. Excellent leadership, communication, and documentation skills. Strong problem-solving mindset and collaborative approach to innovation. What We Offer: Competitive salary and comprehensive benefits package. A collaborative work environment that values innovation and growth. Opportunities for professional development and career advancement. The chance to contribute to life-changing medical device solutions.

Role and Responsibilities Own and lead the entire program lifecycle from inception to delivery for our mobile and web-based software projects. Help to define and then track and manage the project milestones, resources, and budget. Work with dev teams to analyse product requirements and drive proposing technical solutions. Work with dev teams to define, review & add valuable feedback for technical designs & solutions. Able to prioritise issues and work with team members to resolve and escalate issues when consensus cannot be established. Collaborate with cross functional stakeholders. Analyse and manage project risks. Track issues and project status and maintain up-to-date project plans. Schedule and facilitate a variety of project meetings, including status and review meetings for team members and project sponsors. Effectively communicate with cross functional stakeholders on project status, schedule baselines, schedule issues, project risks and major decisions. Maintain intense focus on delivering to all committed milestones and holds the project team accountable by holding weekly project status reviews. Build capability within the project team to accomplish the project goals and deliver the product to market on time. Must be flexible and creative in thinking to execute to a timeline when plans do not go as expected. Qualifications and Skills An experienced professional with minimum 7 years of experience , who can understand our business and technical needs and establish project direction, scope, timing and staffing that will enable us to deliver successful products. Previous technical program management or engineering management roles for technology-based projects and should be familiar with all aspects of these types of projects including various project management and systems development methodologies. B.E./B.Tech in Computer Science or a related field. Minimum 2 years of experience in technical program management or engineering management , preferably with medical device and hardware/technology products as well as consumer health products. Minimum 4 years of software design and development experience with web-based or mobile software with any front end or backend technologies Fair experience in the formal project management process, methods and tools; PM certifications are a plus. Ability to articulate and document objectives, progress and issues effectively to technical and nontechnical audiences. Ability to understand business requirements, as well as technical solutions. Have a solid understanding or willingness to learn FDA, ISO13485 quality system requirements for product and software development. Experience with agile development. Must have a strong flair to make decisions for the projects in general and in conflicting situations. Must have excellent planning and organization skills. Must have strong demonstrated teamwork skills. Ability to manage resources across different internal and cross-organizational groups to get things done. Exquisite attention to detail. Perks and benefits We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team

Key Responsibilities • Design end-to-end data workflow architecture using Alteryx Designer, Server, and Connect. • Translate HLS use cases into technical workflows, including patient journey analytics, claims automation, and real-world evidence processing. • Integrate Alteryx with cloud platforms, EMR systems, SQL-based data warehouses, and visualization tools. • Ensure compliance with HIPAA, GxP, FDA, and other regulatory standards. • Guide the data governance, security, and quality framework across solutions. • Collaborate with clinical analysts, data scientists, and IT to deliver analytics solutions aligned with business goals. • Provide thought leadership, mentor junior Alteryx resources, and contribute to CoEs. Required Skills & Qualifications • Deep expertise in Alteryx Designer, Alteryx Server, and related tools. • Proficient in SQL, Python, and integrating workflows with cloud ecosystems (AWS, Azure, GCP). • Strong understanding of healthcare data models (claims, EMR/EHR, HL7/FHIR). • Mandatory: Minimum 3-5 years of experience working with healthcare or life sciences datasets . • Familiarity with regulatory frameworks (HIPAA, FDA, GxP). • Strong communication and stakeholder management skills.

Manufacturing operations, ensuring GMP compliance and safety. Monitor Manufacturing/production, maintain batch records and SOPs, assist with audits, and drive process improvements to enhance efficiency, reduce costs, and improve product quality.

Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness of the QMS and identify areas for improvement. 4. Lead corrective action and continuous improvement initiatives to address quality issues and improve processes. 5. Develop and maintain quality-related documentation, including procedures, work instructions, and records. 6. Provide training and support to employees on QMS policies, procedures, and requirements. 7. Manage and analyse quality data, including customer complaints, internal rejects, and supplier performance. 8. Collaborate with cross-functional teams, including production, engineering, and procurement, to ensure quality requirements are met. 9. Maintain relationships with external parties, including customers, suppliers, and certification bodies. 10. Stay up-to-date with changes in regulations, standards, and industry best practices. # Requirements: 1. Bachelor's degree in a relevant field (e.g., QMS/BE/MBA). 2. Minimum 8 -10 years of experience in a QMS role, preferably in the plastic molding industry. 3. Certification in a recognized quality management standard (e.g., ISO 9001, IATF 16949). 4. Strong knowledge of quality management principles, including lean manufacturing, Six Sigma, and continuous improvement. 5. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 6. Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions. 7. Proficient in Microsoft Office and quality management software. # Nice to Have: 1. Experience with industry-specific regulations and standards (e.g., FDA, EU MDR). 2. Certification in a related field (e.g., quality engineering, supply chain management). 3. Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness of the QMS and identify areas for improvement. 4. Lead corrective action and continuous improvement initiatives to address quality issues and improve processes. 5. Develop and maintain quality-related documentation, including procedures, work instructions, and records. 6. Provide training and support to employees on QMS policies, procedures, and requirements. 7. Manage and analyse quality data, including customer complaints, internal rejects, and supplier performance. 8. Collaborate with cross-functional teams, including production, engineering, and procurement, to ensure quality requirements are met. 9. Maintain relationships with external parties, including customers, suppliers, and certification bodies. 10. Stay up-to-date with changes in regulations, standards, and industry best practices. # Requirements: 1. Bachelor's degree in a relevant field (e.g., QMS/BE/MBA). 2. Minimum 8 -10 years of experience in a QMS role, preferably in the plastic molding industry. 3. Certification in a recognized quality management standard (e.g., ISO 9001, IATF 16949). 4. Strong knowledge of quality management principles, including lean manufacturing, Six Sigma, and continuous improvement. 5. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 6. Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions. 7. Proficient in Microsoft Office and quality management software. # Nice to Have: 1. E xperience with industry-specific regulations and standards (e.g., FDA, EU MDR). 2. Certification in a related field (e.g., quality engineering, supply chain management). 3. Experience with quality management software (e.g., QMS, EQMS)

* Having an instrumental and wet lab. * Experience of GC -HPLC & all Lab Instruments * Documentary work, SOP preparation activity * ISO, GMP, FDA, WHO Audit Faced. Required Candidate profile * Attention to detail and accuracy * Documentation and report writing skills * Ability to work in a team and under regulated environments

• Having an instrumental and wet lab. • Manpower handling. • Experience of GC -HPLC & all Lab INSTRUMENTS. • Documentary work, SOP preparation activity. • ISO, GMP, FDA, WHO Audit Faced

Description. Regulatory Associate. 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. Essential Functions. Assists with preparation of product development documents including gap analyses and clinical development plans.. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. 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.. Summary. Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include the creation of submission documents to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities.. Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.. You will be responsible for developing creative solutions to challenging issues associated with the design, development, and sustaining engineering for our new and existing Disposable subsystems of dialysis product portfolio. The successful candidate will possess solid “hands-on” technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.. Leads the evaluation and development of mechanical and Fluid control systems by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.. Leads team in defining project strategies, developing goals, and ensures project scope is defined and controlled. Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies. Ensures successful integration of mechanical design entities with interface Systems and consumable components.. Contributes to troubleshooting and problem solving efforts related to mechanical and regulatory aspects of the design and interfaces with other design constituents.. Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards within area of responsibility/expertise. Defines the required tasks, test plans, deliverables, and technical direction. Constructs detailed, accurate project schedules interfacing with product development, quality, regulatory, manufacturing, and other cross functional teams.. Contributes to development and documentation of mechanical systems architectures.. Able to design Plastic components with expertise in manufacturing of plastic components. Able to effectively transition products to manufacturing and ensure robust products and manufacturing processes. Improves mechanical designs that are optimized for production, reliability, regulatory compliance and cost.. Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing. Ensures Systems that are optimized for production, reliability, regulatory compliance, and cost.. Performs in-depth mechanical engineering analysis/FEA/CFD and calculations.. Responsible for integration of deliverables from sub-system design teams and external partners.. Resolves competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.. Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s).. Qualifications. A graduate or a post graduate in Mechanical or related engineering and 14+ years related experience. Prior experience in Renal device/Medical domain is a plus.. A demonstrated track record in Plastic component design and development, preferably medical devices or other highly regulated product domain such as aircraft/automotive/defense industries.. A proven track record of effectiveness in a fast paced environment.. Proven ability to create results within budget, timeline, and product/project deliverables.. Reasonable Accommodation. Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link. Recruitment Fraud Notice. Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.. Show more Show less

Description. Sr Medical Writer (CTT). 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. Mentors and leads less experienced medical writers on complex projects, as necessary.. Acts as lead for assigned writing projects.. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. -Develops or supports a variety of documents that include, but not limited to:. Clinical study protocols and clinical protocol amendments;. Clinical study reports;. Patient narratives;. Clinical development plans;. IND submissions and annual reports;. Integrated summary reports;. NDA and (e)CTD submissions;. Investigator brochures, as well as;. Clinical journal manuscripts, clinical journal abstracts, and client presentations.. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team providing review commentson draft and final documents.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.. Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Trial transparency deliverables, protocol registration, protocol maintenance task, result posting for(CT.gov and EudraCT). Redaction of protocol and SAP (Statistical Analysis Plan). Qualifications. Minimum 7 years of experience in Medical Writing and atleast 5+ years of experience in Clinical Trial Transparency(CTT). Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. 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.. Summary. Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus. Leading the clear and accurate completion of medical writing deliverables. Managing medical writing activities associated with individual studies. Coordinating these activities within and across departments. Completing a variety of documents, adhering to established regulatory standards. Coordinating quality and editorial reviews. Acting as peer reviewers for the internal team. Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs. Performing online clinical literature searches and complying with copyright requirements. Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff. Mentoring and leading less experienced medical writers on complex projects. Developing deep expertise on key topics in the industry and regulatory requirements. Working within budget specifications for assigned projects. Show more Show less

Description. Sr Regulatory Associate (CMC). 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.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations 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

Description. Medical Writer II (CTT). 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. Mentors less experienced medical writers on projects, as necessary.. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Working knowledge of drug development process and regulatory guidelines.. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned.. Minimal travel may be required (less than 25%).. Qualifications. Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing.. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries.. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. 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

Description. Regulatory Associate (CMCPre and post approval ). 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. Assists with preparation of product development documents including gap analyses and clinical development plans.. Minimum 2 years of relevant experience. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. Qualifications. MS in science/healthcare field, or equivalent combination of education and experience.. Minimum 2 years of relevant experience. Excellent interpersonal / communication skills.. Advanced skills in Microsoft Office Applications.. Good time and project management skills, preferred.. Strong analytical skills and attention to detail.. Ability to work both as a team member and independently and to understand and carry out detailed instructions.. Ability to interact with staff from multiple departments.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred.. Fluent in speaking, writing, and reading English.. 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

Role & responsibilities : Lead, manage, and coordinate the Execution and Commissioning teams across multiple project sites including Vizag, Western India, and Hyderabad to ensure seamless integration and delivery of instrumentation and control systems. Plan, monitor, and control project execution activities by tracking project milestones, resource allocation, man-hour utilization, and adherence to timelines using standard project management tools and dashboards. Provide expert-level troubleshooting and root cause analysis for complex field instrumentation, process control systems, PLC/DCS hardware and software faults, SCADA systems, and fieldbus communications (e.g., HART, PROFIBUS, Modbus). Execute advanced diagnostics, calibration, repair, and functional testing of critical field instruments including pressure, temperature, level, flow transmitters, analyzers, control valves, valve positioners, and final control elements in accordance with OEM guidelines and ISA standards. Direct and supervise site instrumentation engineers and technicians in the installation, loop checking, pre-commissioning, and commissioning activities ensuring strict compliance with project specifications, P&IDs, hook-up drawings, and loop diagrams. Read, interpret, and update technical documentation such as P&IDs, loop wiring diagrams, logic diagrams, control philosophy documents, instrument index sheets, and calibration records to reflect actual site conditions (As-Built). Ensure rigorous adherence to HSE (Health, Safety & Environment) policies, carrying out Job Safety Analysis (JSA), Permit to Work (PTW) systems, and compliance with national and international safety standards. Validate and verify the performance of integrated control systems through Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and Performance Guarantee Tests (PGT) in coordination with vendors and third-party agencies. Manage subcontractors and OEM service teams to ensure timely and quality execution of electrical, instrumentation, and automation works. Drive continual improvement initiatives and recommend design or operational changes based on site learnings to improve system reliability, maintainability, and process optimization. Preferred candidate profile: B.Tech / B.E. Instrumentation Engineering with 15+ Years of Experience in Instrumentation & Control Systems Execution, Erection, and Commissioning in Pharma & Life Sciences Industries. Key Skills Required: Strong Electronic Troubleshooting Skills: Proficient in diagnosing and resolving complex issues related to instrumentation, control systems, and automation equipment. Effective Leadership Abilities: Capable of leading cross-functional teams, providing clear direction, and ensuring high performance in dynamic project environments. High Level of Technical Expertise: Demonstrates in-depth technical knowledge of instrumentation, process control systems, and engineering best practices. Broad Engineering Insight: Ability to comprehend and integrate various engineering disciplines, processes, and procedures within project execution and commissioning activities. Excellent Negotiation & Persuasion Skills: Strong capability to influence, negotiate, and manage stakeholders, vendors, and contractors to drive project success. Composure Under Pressure: Maintains confidence, sound judgment, and decision-making ability during high-pressure situations and critical project phases. Outstanding People Management Skills: Skilled in mentoring, motivating, and managing diverse teams to achieve organizational and project objectives.

1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries 2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017.

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products and services. Excellent problem-solving and analytical skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Familiarity with industry-specific software and systems.

Description Medical Writer II (CSR Narrative exp Only) Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Mentors less experienced medical writers on projects, as necessary, Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision, Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures, Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency, Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables, Serves as peer reviewer on internal review team Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format, Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget, Performs on-line clinical literature searches, as applicable, Working knowledge of drug development process and regulatory guidelines, Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing, Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership, Completes required administrated tasks within the specified timeframes, Performs other work-related duties as assigned, Minimal travel may be required (less than 25%), Qualifications Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing Good Experience of independent authoring and reviewing CSR Narratives only, Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise, Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide, Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach, Strong proficiency in Word, Excel, PowerPoint, email, and Internet, Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information, 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, 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 Medical Writer II (CSR Narrative) Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Mentors less experienced medical writers on projects, as necessary, Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision, Develops or supports a variety of documents that include but not limited to: Clinical study protocols and clinical study protocol amendments; Clinical study reports; Patient narratives; Annual reports; Investigator brochures, Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency, Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables, Serves as peer reviewer on internal review team Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format, Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget, Performs on-line clinical literature searches, as applicable, Working knowledge of drug development process and regulatory guidelines, Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing, Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership, Completes required administrated tasks within the specified timeframes, Performs other work-related duties as assigned, Minimal travel may be required (less than 25%), Qualifications What were looking for Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing Good Experience of independent authoring and reviewing CSR Narratives only, Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise, Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide, Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach, Strong proficiency in Word, Excel, PowerPoint, email, and Internet, Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information, 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, 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,

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products and services. Excellent problem-solving and analytical skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Familiarity with industry-specific software and systems.

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM) Dexcom began as a small company with a big dream: To forever change how diabetes is managed To unlock information and insights that drive better health outcomes Here we are 25 years later, having pioneered an industry And we're just getting started We are broadening our vision beyond diabetes to empower people to take control of health That means personalized, actionable insights aimed at solving important health challenges To continue what we've started: Improving human health, We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable We've already changed millions of lives and we're ready to change millions more Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions We'll get there by constantly reinventing unique biosensing-technology experiences Though we've come a long way from our small company days, our dreams are bigger than ever The opportunity to improve health on a global scale stands before us, Meet The Team At Dexcom, the Firmware Verification and Validation team employs advanced technologies for product testing We focus on automating tests and continually enhancing our solutions Our commitment to quality ensures we deliver top-tier products to our customers, W here you come in You execute existing test cases and develop/modify test interfaces for new or modified firmware features to validate next-generation CGM transmitters, You create test plans, test reports, traceability matrices, and other required documentation for test projects in an FDA-regulated quality environment, You proactively identify and mitigate risks and resolve roadblocks, You understand and apply principles of low-power systems design and implementation, You design, implement, and test new products, as well as improve existing products, You identify and implement engineering and quality process improvements, You work with analog and digital hardware interfaces and software operating systems, You perform other duties as assigned, What Makes You Successful You have in-depth knowledge and expertise in at least one programming language with proven experience You have hands-on experience with Java or C# and other object-oriented programming languages, You have experience with automated test development and are familiar with a wide variety of automated testing frameworks, You can perform initial debugging procedures by reviewing configuration files, logs, or code pieces to determine the breakdown source You document software defects using a bug tracking system and report defects to software developers, You participate in design reviews and provide input on requirements, product design, and potential problems You provide technical guidance and mentorship for junior engineers, You have prior experience in embedded programming, particularly with low power microcontrollers in battery-powered systems, You are proficient in embedded software and mobile application testing, You have experience working with the FDA design control process, You are familiar with the product development process for medical devices, including design control and GMP (Good Manufacturing Practice) requirements, You have knowledge of embedded firmware testing, You understand Bluetooth Low Energy (BLE) specifications, You have experience in leading or helping lead one or more projects, Experience And Education Requirements Typically requires a bachelors degree in technical discipline with 2-5 y ears of?industry experience Travel Required 0-5% To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions Dexcom does not accept unsolicited resumes or applications from agencies Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location Dexcom is not responsible for any fees related to unsolicited resumes/applications,

Assists in the maintenance of registrations and licenses of the products in RA systems and database such as SharePoint and other team folders as necessary. Performs labelling reviews and assisting in project creation in the Artwork Management system (WebCenter) as needed. Ensures timely submission of in renewal, site registrations and minor product submissions to relevant Health Authorities in APAC countries. Ensures effective communication across RA (top-down and botom-up) Ensures timely Veeva Vault update related to LCM activities such as MA renewal, site registration, and other minor product submissions as needed. Supports in the request of samples collection via K2 system. Generates regional reports, process vendor payments and other country-related requests. Provides support on other country regulatory and cross functional activities as necessary. Conducts timely regulatory intelligence search in the relevant countries and update Country Regulatory Tool system as necessary. Takes part in Regional/Global or local hub initiatives that are relevant to support the region and hub. Supports the review and revision of hub processes to achieve efficiency across hub. Able to travel as per business need. Other Activities: a) Strategy Alignment -For Site Registration submissions only, ensures alignment with country on submission strategy as required. b) Dossier Readiness - Performs labelling reviews and assists in project creation in Artwork Management system. c) Application Submission - Supports country in renewal and minor product submissions to relevant Health Authorities. - Assists overall the maintenance of registrations and licenses of the products in RA systems and database. - For Site Registration submissions only, ensures timely submission/dispatch of the dossier related to submission and timely Veeva Vault updates. d) Application Approval - Supports country in renewal and minor product submissions to relevant Health Authorities. - Assists overall maintenance of registrations and licenses of the products in RA systems and database. e) Product Maintenance - Assists overall hub in the maintenance of registrations and licenses of the products in RA systems and database. f) Others - Provides support on other country regulatory and cross functional activities. - Generates reports, request samples collection, process vendor payments Who you are: Bachelors or Masters in Pharmacy OR p.HD Min 5-10 Years of experience in Indian Regulatory Market Fluent in written and spoken English Experience in CDSCO, Import and State FDA

Roles & Responsibilities: 1. Product Registration: Handle the registration of products under FDCA (Food and Drugs Control Administration) for necessary approvals. 2. Label Claim Verification: Coordinate with the Formulation & Development team to confirm and validate claims mentioned on product labels and the regulatory classification of each product. 3. Artwork Coordination: Work closely with the sales team to ensure that product artworks (for existing and new products) meet all relevant regulatory requirements. 4. Renewals & Compliance: Manage the timely renewal of product approvals under applicable regulatory bodies, maintaining full compliance throughout the product lifecycle. Qualifications: 1. Bachelors or master’s degree in pharmacy , chemistry, or a related field. 2. 1–2 years of experience in regulatory affairs (preferably in cosmetics, personal care, or pharma). 3. Good knowledge of FDCA and other relevant cosmetic product regulations. 4. Strong communication, coordination, and documentation skills. 5. Detail-oriented with a proactive approach to compliance and deadlines.