Proclinical is currently recruiting for a Medical Writer with a biopharmaceutical company located in Durham, NC.
- 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 clinical writing process.
- Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
- Interfaces with external groups (e.g., PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions.
Skills and Requirements:
- Bachelor of Science required, with relevant writing experience, or bachelor's degree in English or communications, with relevant science experience.
- American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
- 3 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/R&D
- 3 years' experience in experimental design and clinical/preclinical data interpretation preferred.
- Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
- Knowledge and experience with Common Technical Document content templates. Working knowledge of current electronic document management systems and information technology.
- Excellent written and oral communication skills. Experience in working with collaborative, cross-functional teams, including project management experience.
- Ability to assimilate and interpret scientific content and translate information for appropriate audience.
- Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
- Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
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.