K Recruiting is hiring: Senior Medical Writer in Union

Job Description

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

• Independently leads and authors clinical regulatory documents (e.g., protocols, subject narratives, clinical study reports, clinical sections of submission documents) per company and regulatory requirements.
• Assists with development and updating of Investigator’s Brochures, Regulatory Briefing Documents, and other regulatory documents.
• Demonstrates expertise as a subject matter expert in document planning and authoring, and interpretation of data, using own judgment and prior work experience.
• Writes and edits abstracts, manuscripts, posters, and presentations for scientific meetings and manuscripts for publication in scientific journals; coordinates the processes involved in submitting such documents to scientific meetings and journals.
• Editorial reviewing of documents for grammar, punctuation, and submission-compliant formatting.
• Providing overall medical writing support for ongoing programs.
• Is recognized as a strong scientific contributor and works collaboratively on cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.
• Applies critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.
• Provides leadership in initiatives to improve medical writing processes and standards.
• Performs other tasks and assignments as needed and specified by management.

Minimum Required Education

• 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.

Required Experience and Skills

• Ability to independently prepare a diverse set of clinical regulatory documents (e.g., study protocols, subject narratives, clinical study reports, clinical sections of submissions, regulatory communications) per regulatory requirements and industry guidelines.
• Ability to critically analyze and present clinical data clearly and objectively, without supervision.
• Demonstrated critical thinking and problem-solving capabilities with an ability to innovate and drive change.
• Experience managing complex writing projects, working with project teams and cross-functional members.
• Excellent oral and written communication and presentation skills.
• Technical expertise in office applications (e.g., Microsoft Office Suite), shared document systems (e.g., SharePoint) and concepts of structured content management.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Writing/Editing, and Science

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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