Company Summary: Leading pharmaceutical client of ours is looking to bring in a key hire in their Regulatory Writing Team. This is a chance to work with one of the most innovative Biotech Companies in the Bay Area who are revolutionizing the treatment of rare diseases!
The Medical Writer will be responsible for:
- Assist in the preparation and review of key study regulatory briefing documents and other regulatory submissions, and annual reports
- Support writing efforts on Company's first NDA, and new INDs/CTAs3rd responsibility
- Collaborate on development of clinical study documents (e.g., Investigator Brochure, protocols, and clinical study reports), in accordance with applicable regulations
- Perform quality control (QC) check of a contracted written documents
The Medical Writer should have the following qualifications:
- Minimum of BS/BA degree in science (Masters, PhD, or PharmD preferred) with at least 4-7 years of relevant regulatory writing experience in the pharmaceutical and biotechnology industry.
- Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
- An ability to work in a fast-paced, cohesive, collaborative team-oriented work environment
- Member of American Medical Writer's Association and/or Medical Writing Certification preferred
- Great Compensation Package
- Career Growth
- Chance to work with some of the brightest people in the industry
If you are interested in the Medical Writer role, then please don't wait to apply.