Regulatory Writing Senior Manager
Advanced Bio-Logic Solutions
- Thousand Oaks, CA
- $56.00 per hour
- Contract
- Full-time
Note:
FULLY REMOTERegulatory Writing Senior Manager
- ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities.
- Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
- Conduct the formal review and approval of authored documents, following applicable standard operating procedures
- With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
- Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
- Provide functional area input for Global Regulatory Plan and team goals Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
- Lead departmental and cross-departmental initiatives, as appropriate
- Generate document timelines.
- Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferred
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- 5+years of experience in medical writing in the Biotech/Pharmaceutical industry
- Doctorate degree OR Master degree and 2 years of experience OR Bachelor degree and 4 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
- Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferred.
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area.
- 5+years of experience in medical writing in the Biotech/Pharmaceutical industry