Principal Medical Writer – Publications
Job Description:
- Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
- Completes a variety of documents that may include clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts
- Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures
- Coordinates quality and editorial reviews
- Ensures source documentation is managed appropriately
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
- Provides feedback to further define statistical output required and document needs
- Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs as necessary
- Performs online clinical literature searches and complies with copyright requirements
- Identifies and proposes solutions to resolve issues, escalating as appropriate
- Provides technical support, training, and consultation to department and other company staff
- Mentors and leads less experienced medical writers on complex projects, as necessary
Requirements:
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Benefits:
- We are passionate about developing our people, through career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture – where you can authentically be yourself
- Learning opportunities and resources
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