Principle Medical Writer

Proclinical is currently recruiting for a REMOTE Principle Medical Writer with a biopharmaceutical company.

Job Responsibilities:

• Responsible for providing clinical regulatory document support to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the writing process.
• Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers.
• Works closely with the Regulatory team(s) on document strategies.
• Serves as a subject matter expert within department for assigned therapeutic/product areas.
• As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product.
• Provides input and feedback to management regarding internal medical writers' work product/quality.

Skills and Requirements:

• Bachelor of Science required, with significant relevant writing experience, or bachelor's degree in English or communications, with significant relevant science experience. Masters or PhD in science discipline preferred with relevant writing experience.
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
• 4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support
• 2 years relevant industry experience preferred.
• 4 years' experience in experimental design and clinical/preclinical data interpretation preferred.
• High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required.

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

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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