Regulatory Writing Senior Manager at Donatech Corporation
Thousand Oaks, CA
About the Job
Position would require the candidate to be a W2 employee of Donatech
US Citizenship/Permanent Resident Required
FULLY REMOTE
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
US Citizenship/Permanent Resident Required
FULLY REMOTE
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