Sr. Medical Writer

Position Summary:
As a Senior Medical Writer, you will serve as a key contributor within the Clinical business unit, combining advanced medical and technical writing expertise with strong project management skills to support regulatory submissions and strategic communications with the FDA. In this role, you will lead the development of high-quality clinical and regulatory documents across various therapeutic areas and stages of development. You will collaborate closely with internal cross-functional teams and external client stakeholders, ensuring timely, compliant, and scientifically sound deliverables.

This position is ideal for a medical writer who thrives in a client-focused, fast-paced consulting environment and is comfortable managing complex projects and contributing strategic input throughout the regulatory submission process.

Duties and Responsibilities:

• Serve as the lead writer for high-impact regulatory and clinical documents, including but not limited to:
  • Investigator’s Brochures (IBs)
  • Clinical Study Reports (CSRs)
  • Clinical Protocols and Amendments
  • IND Modules
  • Briefing Documents
  • NDA/BLA modules and supporting materials
• Collaborate cross-functionally with Regulatory Affairs, Nonclinical, Medical Device, and CMC teams to gather scientific and technical content required for submissions.
• Oversee and manage writing projects from initiation to final delivery, including content planning, drafting, revisions, stakeholder reviews, and quality control.
• Provide project management support, including but not limited to:
  • Project budget analyses
  • Timeline development and tracking
  • Document exchange workspace implementation and maintenance
  • Communication facilitation among team members (BCG and client)
  • Document tracking/version control, collection and organization
• Ensure all documents adhere to FDA, ICH, and internal quality and formatting standards.
• Provide strategic input and regulatory insight to guide content development and structure, ensuring alignment with submission goals and regulatory expectations.
• Participate in client meetings and FDA preparation sessions; contribute to overall regulatory strategy discussions.
• Provide peer review and editorial support for documents authored by others, ensuring consistency, clarity, scientific accuracy, and compliance.
• Track and manage multiple concurrent projects and deadlines while maintaining a high standard of quality and efficiency.
• Serve as a subject matter expert on regulatory medical writing and document preparation for FDA submissions.
• Contribute to the continuous improvement of writing templates, processes, and internal best practices.

Qualifications:

Required:

• Bachelor’s degree in a life sciences or medical-related field; advanced degree (MS, PharmD, PhD) strongly preferred.
• Minimum of 5–7 years of hands-on experience in regulatory or medical writing within the FDA-regulated pharmaceutical, biotechnology, or CRO environment.
• Demonstrated expertise in authoring and managing regulatory submission content including INDs, NDAs, BLAs, and other FDA documents.
• Strong project management and organizational skills; PMP certification strongly preferred.
• Deep understanding of ICH guidelines, FDA regulatory requirements, GCP, and the clinical development lifecycle.
• Proven ability to manage complex writing projects with multiple stakeholders under tight timelines.
• Strong written and verbal communication skills, including scientific storytelling and content clarity.
• Proficiency in Microsoft Word, Adobe Acrobat, and commonly used document management systems.

Preferred:

• Experience working in a consulting or client-facing environment.
• Familiarity with project management tools and collaborative software such as Veeva Vault, Smartsheets, Box, or StartingPoint.
• Direct experience preparing briefing packages or materials for FDA meetings and regulatory interactions.
• Experience in therapeutic areas including oncology, rare disease, or immunology is a plus.

Key Performance Indicators:

• Delivery of high-quality documents in accordance with regulatory timelines and client expectations
• Contribution to client satisfaction and repeat business through effective communication and collaboration
• Demonstrated ability to lead multiple concurrent projects and support cross-functional team needs
• Consistent adherence to regulatory standards, internal SOPs, and quality benchmarks
• Active participation in knowledge-sharing, team mentorship, and continuous process improvement

Essential Skills:

• Exceptional writing, editing, and formatting proficiency
• Strong analytical thinking, attention to detail, and scientific acumen
• Ability to communicate complex concepts clearly to varied audiences
• Team-oriented with a collaborative mindset and client-service focus
• Strong organizational, prioritization, and time management skills
• Discretion and professionalism when handling confidential information