Senior Medical Writer (CSR, IB , Protocol)

We are seeking a highly experienced Senior Medical Writer to lead the clear and accurate completion of medical writing deliverables. This role involves managing all medical writing activities for individual studies, ensuring scientific information is presented with clarity and accuracy. The ideal candidate will have a strong background in the biopharmaceutical industry, a deep understanding of regulatory standards, and proven experience in writing a variety of key documents, including Clinical Study Reports (CSRs), Investigator Brochures (IBs), and Protocols.

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.