Manager, Medical Writing
Global Regulatory Writing & Consulting (GLOBAL)
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $140,000 - $160,000 per year
About the role
- Oversee and lead the development of high-quality scientific documents, including clinical study reports, regulatory submission documents, publications, and other medical communications
- 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
- 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
- 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
- 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
- Provide detailed reviews and edits for accuracy, scientific content, grammar, style, and formatting
- Provide training and development opportunities for junior writers, improving their skills in clinical and regulatory writing.
Requirements
- Advanced degree (PhD, MD, PharmD, MS, or equivalent) in a scientific discipline (e.g., life sciences, pharmacology, biostatistics)
- 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.
- 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
- High attention to detail and a strong commitment to quality.
- Medical Writing Certification (e.g., from the American Medical Writers Association, or similar) is a plus but not required.
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingclinical study reportsregulatory submission documentsscientific publicationseditingproofreadingproject managementclinical researchbiostatisticsregulatory documents
Soft Skills
leadershipcommunicationattention to detailquality commitmentmentoringcollaborationtime managementinterpersonal skillswriting clarityproblem-solving
Certifications
Medical Writing CertificationAmerican Medical Writers Association certification