Lead Med Writer,R&D Applied Life Science Requisition ID: 72977 Date: Feb 4, 2026 Location: Bengaluru, KA, IN Department: R&D Description: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. **Job Summary** The **Senior/Lead Medical Writer** role with the Applied Research & Medical Affairs team is focused on scientifically communicating medical information, requiring strong scientific knowledge and writing skills. The position involves authoring and overseeing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Post-Market Surveillance Reports (PMSRs), PSURs, and PMCF documents. It requires expertise in literature evaluation, critical analysis, and synthesizing data to ensure regulatory compliance. As a subject matter expert and primary team contact, the role includes guiding content development, managing projects, and quality assurance, ensuring timely delivery of high-quality documents that align with clinical and regulatory standards. **Essential Duties and Responsibilities** + Lead the creation of CERs, CEPs, PMSRs, PSURs, and PMCF-related documents. + Continually enhance knowledge of therapeutic areas, competing devices, and current clinical and market trends. + Develop strategies for literature searches and data extraction, focusing on article review, screening, and summarization. + Engage in extensive literature searches to support targeted product areas and associated clinical investigations. + Remain updated on current regulatory landscapes and evolving trends. + Analyze and distill literature search outcomes, assessing risks, therapeutic alternatives, and device benefits to support risk evaluations. + Conduct thorough literature appraisals and author clinical summaries elucidating product challenges and treatments. + Assess data concerning equivalent competitor devices. + Verify the factual accuracy of authored documentation. + Coordinate with stakeholders to integrate product details into CERs, adhering to established timelines. + Manage project accounts, ensuring the timely delivery of all contractual obligations. + Oversee the technical and operational aspects of projects from start to finish. + Mentor writers to successfully execute assigned deliverables. + Maintain regular communication with primary and support writers concerning project progress. + Review and resolve queries during project initiation and update meetings. + Guide team members in product comprehension, literature search strategies, and systematic literature review processes. + Interacts and coordinates with internal and external stakeholders on significant matters involving functional and technical expertise. + Monitors assigned projects and manage workload, taking ownership of the activities in addition to finding potential solutions to issues. + Other duties as assigned **Education & Experience** + Degree or postgraduate qualification in Life Sciences or pharmacy or Biomedical Engineering with 5-8 years of relevant experience. + Atleast 8 years in the medical device clinical affairs sector, with comprehensive knowledge in clinical evaluation documentation. + Ability to pinpoint critical information requirements to facilitate decision-making in clinical evaluations. + Significant experience in conducting thorough literature reviews and assessing scientific data. + Strong analytical and critical thinking skills. + Experience in Clinical evaluation and post-market deliverables review. + High attention to detail and proficiency in handling multiple projects. + Effective communication, presentation, and teamwork skills. + Consistent work ethic and dedication to meeting project deadlines. + Ability to manage a team of 2-4 writers. **Preferred Knowledge, Skills and Abilities** + Experience with working in the pharmaceutical/CRO industry is preferred. + Substantial understanding of medical devices and broad medical knowledge. + Familiarity with regulatory frameworks such as FDA, EU MDR, MEDDEV, IMDRF, and MDCG. + Passionate about technical writing and scientific documentation. + Proficient written, verbal, and presentation communication skills. + Keeps informed about the latest scientific developments for their application in ongoing projects. + Demonstrated ability to think Critically and Analytically + Ability to work as part of a team as well as independently + Ability to work on medical literature and research data (via medical journals, and resources like Medline, PubMed, etc.) **Shift & Travel Requirements** + Job Type: Full-time + Travel: No + Occasional on-call work required + Prefer 12pm – 9pm IST. Willingness to work outside of these hours as needed. West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.