Director of Medical Writing

Proclinical, in support of our client, are seeking an individual to fill the role of Director of Medical Writing, based in Cambridge, MA. The successful candidate will play a leadership role in future key regulatory submissions to the FDA and EMA.

Responsibilities

• Provide leadership in planning and completing key submission documents for submissions to the FDA and EMA.
• Contribute to overall project management and to cross functional working groups.
• Manage the work of CRO contract writers, as needed.
• Work with the clinical and regulatory teams to prepare protocols, clinical study reports, Investigator's brochures, safety updates, and IND clinical sections in CTD format under strict timelines.
• Participate in recruiting and mentoring of staff, and budget planning.

Skills And Qualifications

• PhD in a Life Science or equivalent and 5+ years in medical writing, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA), with supervisory experience.
• Experienced in the preparation of protocols, study reports, investigator brochures, safety updates, and IND clinical sections.
• Ability to communicate and write clearly, concisely, and effectively, with an aptitude for compilation, analysis, and presentation of data.

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) 336-842-8682 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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