Senior Medical Writer - Oncology

Job Description

The Senior Medical Writer is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio.

With minimal oversight, the Senior Medical Writer:

• Demonstrates independence in preparing clinical regulatory documents (e.g., protocols, clinical study reports, investigator’s brochures, clinical sections of submissions) per company and regulatory requirements.

• Applies an in-depth knowledge of medical writing responsibilities, including document planning and authoring, and interpretation of data.

• Is a scientific contributor and works collaboratively on document-specific cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.

• Applies knowledge of clinical development, relevant regulations, disease areas, and company products.

• Applies critical thinking, problem solving and negotiation skills to identify innovative solutions to challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.

• Applies knowledge of medical writing-specific tools and technology platforms.

• Participates in or leads initiatives to improve medical writing processes and standards.

• May participate in orientation and coaching of junior team members or contract writers.

Education Requirement and skills:

• Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine).

• Bachelor’s degree with 5+ years, master’s degree with 4+ years, or doctorate degree with 3+ years of relevant medical writing experience in the pharmaceutical and/or biotech industry.

• Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (e.g., clinical study reports, investigator’s brochures, clinical sections of submissions) per regulatory requirements and industry guidelines.

• Ability to present clinical data clearly and objectively, with minimal supervision.

• Demonstrated critical thinking and problem-solving capabilities.

• Ability to manage multiple projects in a deadline-driven environment, work collaboratively, and lead authoring teams of medical writers and cross-functional members.

• Excellent oral and written communication and presentation skills.

• Technical expertise in office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint); familiarity with concepts of structured content management preferred.

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