Job Description

Position Overview:

This position supports the Clinical Development, Clinical Operations and Regulatory Affairs teams in writing and coordinating the writing and review of technical documents.

Key Responsibilities:

The Senior Medical Writer is responsible for the development and management of medical writing deliverables in support of key functions including Clinical Development, Clinical Operations, and Regulatory Affairs.

The specific responsibilities of this role include, but are not limited to:

• Serve as the primary writer for a range of medical writing projects including the design, planning, and preparation of documents supporting clinical development (e.g., study protocols, study reports, investigator brochures, etc.), regulatory activities (e.g., briefing materials, clinical modules, etc.), and manuscript preparation.
• Ensure that documents are high-quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to relevant internal and external (e.g., regulatory) guidelines.
• Review, edit, and ensure the quality of documents prepared by other medical writers (internal or external) and functional area representatives.
• Ensure that medical writing activities are coordinated with other departments, including Regulatory Affairs, Clinical Development, Pharmacovigilance, etc., and that timelines are met.
• Ensure consistent messaging across documents (nonclinical, clinical, regulatory, etc.).
• Work collaboratively with colleagues in other departments (e.g., Clinical Development, Clinical Operations, Regulatory Affairs, Statistics/Data Management, Pharmacovigilance, etc.).
• Help maintain the Trial Master File and ensure it is current.
• Train and mentor junior writers and work closely with other members of the Medical Writing team.
• Other tasks as required.

Qualifications:

• Excellent written and oral communication skills.
• Well-developed organizational skills, thorough with excellent attention to detail.
• Strong analytical and problem-solving ability, innovative and creative, good judgment; ability to identify risks to timelines and data integrity.
• Self-motivated with the ability to work both independently and collaboratively as a member of a team; good leadership ability.
• Knowledge and understanding of FDA and ICH guidelines, Good Clinical Practices (GCP), medical terminology, clinical trial methodology, and drug development processes.
• Oncology drug development experience desirable but not required.
• Able to travel domestically and internationally approximately 2-3 times a year if required.

Education & Experience:

• A bachelor’s degree, preferably in a scientific or technical discipline, is required.
• A minimum of 5-7 years of previous professional medical writing experience in a pharmaceutical, biotechnology or medical-related field.

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