Job Description
Senior Medical Writer- Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Senior Medical Writer with a biopharmaceutical company in South San Francisco, CA who possesses:
- BS degree required, MS degree preferred, 4+ years of industry experience with medical writing internally at a biotech company
- Must have experience with drafting SOP's regarding medical writing
- Must have experience with drafting up IND's, NDA's, and BLA's, experience with EU preferred
- Experience with DSUR writing experience is a big plus
Email resumes to hyazarlou@simplybiotech.com or call 858.496.7758
FULL DESCRIPTION: The Senior Medical Writer is a key individual responsible for writing, reviewing, and editing clinical documents. This is an individual contributor position with team leadership responsibilities. The Senior Medical Writer will work closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion and in compliance with ICH/GCP/regulatory guidelines, SOPs, and company goals. This individual may also support other medical writing activities as requested.
The selected candidate will be responsible for:
- Write, review, and edit clinical regulatory documents such as clinical study protocols,
- CSRs, Investigator's Brochures, IND/NDA/BLA clinical summaries, and other documents as required for submissions
- Interpret statistical and clinical data with appropriate guidance/direction from teams and management
- Arrange and conduct review meetings with teams and independently resolve document content issues and questions arising from the writing/review process
- Work with cross-functional groups, including clinical research, biostatistics and drug safety, to set priorities for document preparation and collaborate on document content.
- Represent Medical Writing on project teams and advise on content and format requirements for various documents
- Develop timelines and communicate writing process and timelines to team members
- Interact with internal and external authors (as needed) and key stakeholders to develop high quality documents
- Provide status/updates of Medical Writing deliverables to management, and create/track timelines
- Contribute to document templates (e.g., protocols, CSRs) and style guides
- Comply with established company policies and procedures, and industry and regulatory guidelines
- May contribute content to safety documents (e.g., DSURs)
- Assist in the development of SOPs for Medical Writing processes
- Provide additional support to the Medical Writing team and the Clinical and Regulatory team as needed
- Other duties as assigned
The selected candidate will also possess:
- BA/BS in one of the life sciences with a minimum of 5 years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 4+ years of relevant medical writing experience
- Ability to work both independently and in cross-functional team environments with minimal supervision.
- Ability to work effectively in a fast-paced environment with multiple high-priority projects
- Project management skills
- Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP)
- Strong written and verbal communication skills. Ability to engage and disseminate information among appropriate stakeholders for effective document production.
- Attention to detail with an ability to detect errors and inconsistencies in various types of documents
Salary Range: $144k-182k/yr
For immediate and confidential consideration, please email your resume to hyazarlou@simplybiotech.com or call 858.496.7758. More information can be found at www.simplybiotech.com