Lead Medical Writer developing essential clinical documents for West Pharmaceutical Services. Focused on regulatory compliance and team mentorship in the R&D department.
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
Engage in extensive literature searches to support targeted product areas and associated clinical investigations
Conduct thorough literature appraisals and author clinical summaries elucidating product challenges and treatments
Mentor writers to successfully execute assigned deliverables
Requirements
Degree or postgraduate qualification in Life Sciences or pharmacy or Biomedical Engineering
5-8 years of relevant experience
Significant experience in conducting thorough literature reviews
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
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