Senior Clinical Content Developer

An experienced Medical Writer is sought to lead the creation of high-quality, scientifically accurate content for publications.

This role requires strong expertise in scientific writing, project management, and collaboration with cross-functional teams.

The ideal candidate will possess a deep understanding of FDA and ICH regulations, as well as experience working with regulatory guidelines and industry standards.

A Bachelor's degree in a relevant discipline is required, with a graduate degree preferred.

Key qualifications include 3-5 years of relevant experience in science, technical, or medical writing, with a strong understanding of medical terminology and principles of clinical research.

• Develop and maintain knowledge of medical literature, regulatory guidelines, and industry standards.
• Collaborate with subject matter experts to create high-quality, scientifically accurate content.
• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manage medical writing activities associated with individual studies, coordinating these activities within and across departments.
• Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides.
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately.
• Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs.
• Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff.
• Mentor and lead less experienced medical writers on complex projects.
• Develop deep expertise on key topics in the industry and regulatory requirements.

• Bachelor's degree in a relevant discipline.
• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
• Experience writing relevant document types required.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.

• Strong presentation, proofreading, collaborative, and interpersonal skills.
• Strong project and time management skills.
• Strong proficiency in MS Office.
• Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information.