Medical Writer Job at West Pharmaceutical | Apply Now
Looking for a rewarding medical writer job in the applied life science domain? West Pharmaceutical Services is hiring experienced professionals for a Medical Writer, R&D role focused on clinical evaluation and regulatory documentation. This opportunity is ideal for candidates seeking a BDS Job or MBBS Job transition into medical device clinical affairs and scientific writing.
Job Details:
- Job Position: Medical Writer, R&D, Applied Life Science
- Job Type: Full-time
About the Company:
At West, a dedicated team is connected by a purpose to improve patient lives that has been at the center of the Company for more than a century. The story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through 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.
Job Description:
This medical writer job 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 country and regulatory standards. Skillful in project coordination, asset management, quality assurance, and team interaction, dedicated to delivering precise, high-quality scientific content within set deadlines.
Qualifications:
Education & Experience
- BDS/MBBS
- 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.
Key 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.
