Regulatory Writing Senior Manager

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