Regulatory Writing Senior Manager

Amgen•Thousand Oaks, CA

7d•$139,582 - $188,846

About The Position

The Regulatory Writing Senior Manager serves as a functional area lead on product teams and leads writing activities for complex product submissions. The role provides regulatory writing expertise, trains and mentors more junior writers, supervises contract and freelance writers, and leads departmental and cross-departmental activities. The position authors or oversees regulatory submission documents, reviews and approves documents according to applicable standard operating procedures, and generates document timelines.

Requirements

Doctorate degree and 2 years of directly related experience; or Master’s degree and 6 years; or Bachelor’s degree and 8 years; or Associate’s degree and 10 years; or high school diploma/GED and 12 years.
Experience with regulatory documents in Regulatory Affairs, Research, Development, or a related area.
5+ years of experience in medical writing in the biotechnology or pharmaceutical industry.

Nice To Haves

Experience with regulatory documents in Regulatory Affairs, Research, Development, or a related area.
5+ years of experience in medical writing in the biotechnology or pharmaceutical industry.

Responsibilities

Author or oversee authoring 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 formal review and approval of authored documents in accordance with applicable standard operating procedures.
Lead regulatory writing activities with limited supervision for complex product submissions, including new and supplemental drug applications and biologics license applications.
Serve as the functional area lead on product teams, such as Global Regulatory Teams, Evidence Generation Teams, Global Safety Teams, and Label Working Groups.
Provide functional area input for the Global Regulatory Plan and team goals.
Supervise contract and freelance writers and mentor junior medical writers as assigned.
Lead departmental and cross-departmental initiatives, as appropriate.
Generate document timelines.

Benefits

Comprehensive employee benefits package, including health and welfare plans for staff and eligible dependents.
Retirement and Savings Plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans and bi-annual company-wide shutdowns.
Flexible work models, including remote work arrangements where possible.
Work/life balance and career development opportunities.