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Regulatory Writing Senior Manager
Thousand Oaks, CA
Job Description
FULLY REMOTE
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.
Key responsibilities include:
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
Preferred 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
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
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.
Key responsibilities include:
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
Preferred 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
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
5+ years
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