Our biopharmaceutical client headquartered in MA is looking to add a Director, Medical Writing (REMOTE) to their team.  This role will be responsible for developing and implementing medical writing strategies, operational plans, and oversight and delivery of the medical writing function throughout the lifecycle of clinical development programs. This role will work collaboratively and strategically with our cross-functional teams and external partners to ensure that writing deliverables generated by the company and third-party vendors are generated with the highest Good Clinical Practice (GCP), Good Documentation Practices (GDP), patient safety and quality standards, in accordance with regulatory requirements, established contractual agreements, budgets and timelines.
Responsibilities: 

• Create and influence medical writing strategies and processes within and across functional areas.
• Provide guidance to colleagues regarding industry and medical writing best practices.
• Create writing guidelines based on familiarity with relevant document templates (e.g., NIH-FDA clinical trial protocol template, FDA/ICH Structure and Content of CSRs)
• Lead in-house and outsourced medical writing team to prepare clinical sections of regulatory documents (e.g., marketing applications, annual reports, briefing books,)
• Coordinate and contribute to preparation of Clinical documents (i.e., Investigator’s Brochures, Clinical Study Reports)
• Ensure and coordinate document quality checks for accuracy, collating reviewers’ comments, adjusting content of documents as required based on internal/external input, and preparation of the final version.
• Maintain and enhance therapeutic area working knowledge, including disease state and compound, for assigned projects and support literature searches required for document generation.
• Maintain and enhance working knowledge of regulatory guidelines and publication guidelines.
• Contribute to process improvement within and across functional areas.
• Work with teams to develop project specific metrics compliant with standard project metrics; influencing or negotiating change of timelines and content with other team members as needed.
• Coordinate activities related to preparation of scientific publications, including, and not limited to, abstracts, posters, manuscripts, and presentations as needed.

Requirements:

• BS/BA in a science or industry-related discipline
• Minimum of 10+ years’ experience in pharmaceutical R&D environment, including at least 3+ years as a Medical Writer.
• Recognized for technical expertise in specific document development.
• Excellent, high-level, end-user computer skills (e.g., word processing, tables, graphics, spreadsheets, presentation, and templates) and Microsoft software suite skills
• Working knowledge of ICH and other regulatory guidelines. Broad knowledge of global pharmaceutical regulatory requirements
• Thorough working knowledge/understanding of clinical trial design, methodology and statistical concepts; working knowledge of the IND/BLA/NDA process and ex-US marketing applications.