Director Medical Writing

Proclinical is looking for a remote Director of Medical Writing for a leading biotech company. The Director, Medical Writing reports to the Executive Director, Medical Writing and will support Clinical Science, Regulatory, and Safety functions.

Job Responsibilities:

• Manage, write, and edit clinical, regulatory, and safety documents for Iovance programs.
• Write clinical study protocols and amendments, Investigator's Brochures, DSURs, and other medical/regulatory documents.
• Develop and manage timelines in collaboration with the Executive Director, Medical Writing. Collaborate cross-functionally to drive projects to completion.
• Write and oversee the review of documents toward regulatory submissions such as INDs and BLAs.
• Other duties as assigned.

Skills and Requirements:

• PhD/master's degree in a life sciences discipline (advanced degree preferred) or equivalent experience and a minimum of 5 years' biopharmaceutical industry experience.
• Experience drafting clinical protocols and Investigator's Brochures. Prior regulatory submission experience preferred, especially work toward IND and BLA submissions.
• Indepth understanding of regulatory/ICH guidelines and GCPs.
• Expert abilities in Microsoft Office Suite, Adobe Acrobat, Visio, and electronic content management systems (SharePoint).
• Experience with cross-functional collaboration and with managing priorities and timelines.
• Strong written and verbal communication skills.
• Experience in oncology drug development.
• Experience working independently and leading teams to successful submissions.

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 929-388-1650 or m.hermiz@proclinical.com.

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

Proclinical Staffing is an equal opportunity employer.

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