Job Description:

Location: REMOTE

Salary: $35.00 USD Hourly - $55.00 USD Hourly

Description: Our client is currently seeking a Regulatory 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.

Must to have Qualifications:

• 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.


• 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

Contact: asheikh@judge.com


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