Manager of Medical Writing

The Manager of Medical Writing will oversee and lead the development of high-quality scientific documents, including clinical study reports, regulatory submission documents, publications, and other medical communications. This role requires leadership, strategic oversight, and hands-on writing skills. The ideal candidate will collaborate with cross-functional teams, including clinical, regulatory, and medical affairs teams, to ensure the delivery of accurate, clear, and well-structured documents that meet industry standards and regulatory requirements.

• Leadership & Team Management: 
  • Lead a team of medical writers, providing mentorship, training, and career development opportunities.
  • Assign tasks, set priorities, and manage timelines to ensure timely and high-quality document delivery.
  • Foster a collaborative and supportive environment within the team.
• Medical Writing Oversight: 
  • Develop and oversee the preparation of clinical study reports (CSRs), clinical study protocols, investigator brochures, regulatory submission documents (e.g., INDs, NDAs), and other scientific/medical documents.
  • Ensure the accuracy, clarity, and compliance of all documents with internal guidelines, industry standards, and regulatory requirements.
  • Review and edit documents for consistency, style, and adherence to medical writing best practices.
• Cross-Functional Collaboration: 
  • Collaborate with clinical, regulatory, biostatistics, and other functional teams to ensure seamless development of medical writing deliverables.
  • Coordinate document preparation, review, and approval processes with internal stakeholders and external partners, such as contract research organizations (CROs).
• Regulatory & Publication Support: 
  • Support the preparation of regulatory submission documents and assist in the response to regulatory agency inquiries.
  • Contribute to the preparation of scientific publications, abstracts, posters, and presentations for medical meetings.
• Process Improvement & Compliance: 
  • Implement and maintain efficient medical writing processes and tools to improve the quality and efficiency of document preparation.
  • Ensure that all writing adheres to current guidelines, including ICH E6, ICH E3, GxP, and other relevant regulatory requirements.
• Quality Control: 
  • Provide detailed reviews and edits for accuracy, scientific content, grammar, style, and formatting.
  • Ensure consistent and high-quality medical writing across all deliverables.
• Training & Development: 
  • Provide training and development opportunities for junior writers, improving their skills in clinical and       regulatory writing.
  • Stay updated on current industry trends and regulations to ensure the team is aligned with best practices       in medical writing.

Qualifications

• Education: 
  • Advanced degree (PhD, MD, PharmD, MS, or equivalent) in a scientific discipline (e.g., life sciences, pharmacology, biostatistics).
• Experience: 
  • Minimum of 5-7 years of medical writing experience, with at least 2-3 years in a leadership or managerial role.
  • Experience in clinical research, regulatory submissions, or biopharmaceutical industry required.
  • Proven experience with clinical trial reports, regulatory documents (e.g., IND, NDA), publications, and other medical communications.
• Skills: 
  • Strong knowledge of medical writing standards and regulatory requirements.
  • Excellent writing, editing, and proofreading skills, with the ability to communicate complex scientific concepts clearly and concisely.
  • Strong project management skills, with the ability to manage multiple projects and meet tight deadlines.
  • Ability to collaborate effectively with cross-functional teams and external partners.
  • High attention to detail and a strong commitment to quality.
• Certifications: 
  • Medical Writing Certification (e.g., from the American Medical Writers Association, or similar) is a plus but not required.

Additional Skills

• Familiarity with regulatory guidelines (e.g., ICH, FDA, EMA) and industry standards (e.g., GxP).
• Proficiency with medical writing tools (e.g., EndNote, Reference Manager, Microsoft Office Suite, Adobe Acrobat).
• Strong interpersonal and communication skills, with the ability to lead and mentor a team.