Medical Writer Job at West Pharmaceutical Services | Apply Now
West Pharmaceutical Services is inviting applications for the role of Medical Writer, R&D within its global Medical Affairs division. This Medical Writer Job is ideal for life science professionals (PharmD, M.Pharm, MBBS) with 3 to 5 years of experience, specifically in the medical device clinical affairs domain. You will lead the development of critical regulatory documents such as Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS) reports, ensuring compliance with EU MDR and FDA standards.
- Job Role: Medical Writer, R&D, Applied Life Science
- Location: Bengaluru
About The Company
West is a century-old leader in the healthcare industry, a legacy that began with supplying penicillin to the US Government during World War II. Today, the Medical Affairs (MA) team is a global function that identifies the clinical value proposition for innovative concepts while ensuring the highest standards of patient safety. The team is responsible for managing the clinical technical documentation that supports global regulatory submissions to the FDA, EU MDR, and other authorities.
Job Summary
You will focus on crafting high-quality clinical and regulatory documents while conducting comprehensive literature searches to assess device risks and benefits. This role requires a blend of technical writing expertise and project coordination skills to meet aggressive timelines.
Essential Duties And Responsibilities
- Responsible for crafting clinical evaluation reports, plans, PMS reports, and PSURs.
- Serve as the contact for daily communication regarding deliverables.
- Prepare queries for project initiation meetings.
- Maintain asset trackers relevant to deliverables.
- Review project-related assets, update trackers, and request additional documentation as needed.
- Coordinate with peer reviewers and technical leaders on timelines for deliverable release.
- Gain knowledge of therapeutic areas, competitor products, and current clinical and market advancements.
- Conduct comprehensive literature searches in support of product lines and associated studies.
- Stay current with emerging clinical landscapes and trends.
- Review and summarize literature search results, assessing risks, alternative treatments, and device benefits.
- Critically evaluate scientific literature and produce clinical summaries that clarify the clinical issues and available treatments.
- Evaluate data regarding similar/competitor devices.
- Perform fact checks on authored documents to ensure country and regulatory compliance.
- Engage in team calls as project demands dictate.
- Commit to quality assurance, confidentiality, and security.
- Adhere to established quality systems, processes, and policy requirements.
Additional Responsibilities
- Notify stakeholders of any open action items in drafts.
- Conduct a self-QA before submitting drafts for review, updating checklists.
- Prepare and distribute meeting minutes for team calls related to assigned deliverables.
- Conduct peer reviews, quality checks, and data validations on drafts.
Education & Experience
- Graduate or Postgraduate in life sciences (PharmD/M.Pharm) with 3 to 5 years’ experience.
- 3+ years of experience in the medical device clinical affairs domain.
- Ability to identify critical information needs and identify roles/individuals to involve for decision-making within clinical evaluation, assessment, and report development.
- Strong experience in conducting literature searches, reviews, and appraisals of scientific data.
- Clear and effective communication, both verbal and written. Excellent critical and analytical thinking skills.
- Able to work effectively with cross-functional teams. Able to manage multiple projects across numerous disciplines.
- Strong communication, presentation, and interpersonal skills with close attention to detail and organization.
- Consistent dedication and strong work ethic to help meet aggressive timelines or multiple projects when necessary.
Preferred Knowledge, Skills And Abilities
- Experience 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 in 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.).
