Senior Medical Writer (CSR, IB , Protocol)

Senior Medical Writer

Roles & Responsibilities

• Leadership & Project Management:

• Lead and oversee the completion of all medical writing deliverables.
• Manage medical writing activities for individual studies with minimal supervision, coordinating across various departments.
• Mentor and lead less-experienced medical writers on complex projects.
• Work within budget specifications for all assigned projects.

• Content Creation & Compliance:

• Complete a wide range of documents, including

  clinical study protocols

  , amendments, clinical study reports, patient narratives, and investigator brochures.
• Adhere to established regulatory standards, including

  ICH E3 guidelines

  , company SOPs, and client-specific requirements.
• Review

  statistical analysis plans

  and table/figure/listing specifications for accuracy and consistency.

• Collaboration & Quality Assurance:

• Coordinate quality and editorial reviews to ensure all documents meet high standards.
• Act as a

  peer reviewer

  to ensure scientific content, clarity, and proper format.
• Build strong working relationships with clients and peers in data management, biostatistics, and regulatory affairs.

• Problem-Solving & Expertise:

• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, providing technical support and consultation to teams.
• Develop and maintain deep expertise on key industry topics and regulatory requirements.

Preferred Candidate Profile

• Education:

  A Bachelor's degree in a relevant discipline; a graduate degree is preferred.

• Experience:

• Professional experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry is required.
• Proven experience writing relevant document types, including

  CSRs, IBs, and Protocols

  .

• Skills:

• Strong understanding of

  FDA and ICH regulations

  is required.
• Extensive knowledge of

  English grammar

  and the ability to communicate clearly.
• Strong familiarity with the

  AMA Manual of Style

  .