Director, Medical Writing

Proclinical is currently seeking a Director of Medical Writing for a biopharmaceutical company located in Cambridge, MA. This senior level role involves managing 4 direct reports. Successful candidate must hold over 8 years of medical writing experience.

Job Responsibilities

• Leading the Medical Writing efforts and strategy on drug development programs and ensuring high quality and on-time writing deliverables in accordance with all applicable regulations.
• Overseeing, developing, and managing medical writers on multiple programs; providing leadership, coaching, guidance, and mentorship; ensuring management and training of external writers/CROs.
• Communicating program goals and priorities to the medical writers on assigned drug development programs.
• Planning, coordinating, overseeing, and driving clinical filing dossiers.
• Writing and editing high-quality and on-time writing deliverables, as needed.
• Contributing to the development of global department standards and implementing process improvements.
• Partnering with both internal and external stakeholders.
• Serving as subject matter expert for Research and Development documents and their production, including clinical document strategies within the drug development program.

Skills and Requirements

• BS in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. MS or PhD and/or professional certification/credentials preferred.
• 10+ years of experience as a medical writer in the sponsor/CRO setting. Sponsor experience strongly preferred.
• Experience with leading, planning, writing, coordinating, and overseeing the clinical dossier for global regulatory filings required. CTA/IND experience is a plus.
• 3+ years of experience as a successful manager of medical writing direct reports.
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
• Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
• Impeccable attention to detail and ability to complete writing assignments in a timely manner with minimal oversight.
• Proficient with MS Office Suite and MS Project.
• Excellent oral and written communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4385 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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