Title:  Medical Writer,R&D,Applied Life Science

Job Summary

The Applied Research & Medical Affairs team within West is responsible for driving the future of the company by identifying and developing innovative products designed to improve patient lives. The scope encompasses technology fields that are adjacent to and transformational to West’s core products. The Medical Affairs (MA) team at West is a global function dedicated to supporting the company's clinical activities and aligning with strategic goals to maintain high standards for patient safety and support regulatory obligations. The team plays a crucial role in identifying the clinical value proposition for innovative concepts.

Through literature research, education, training, and communication, the MA team supports the safe use of West's products. These activities demonstrate the company's commitment to containing and delivering injectable therapies that improve the health of patients worldwide. The team prepares and manages the necessary clinical technical documentation to support EU MDR, FDA, and other global regulatory submissions. 

Medical Writer, R&D is focused on developing clinical and regulatory documents, including Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Post-Market Surveillance (PMS) reports, and Periodic Safety Update Reports (PSURs). Expertise in conducting literature reviews, analyzing competitor data, and summarizing clinical risks and benefits while adhering to the country and regulatory standards. Skillful in project coordination, asset management, quality assurance, and team interaction, and dedicated to delivering precise, high-quality scientific content within set deadlines.

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/BDS/MBBS) or Bio-Medical Engineering 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 high attention to detail and organization.
•  Consistent dedication and strong work-ethics to help meet aggressive timelines or multiple projects when necessary

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.