Regulatory Writing Sr Mgr

Regulatory Jobs; United States; Remote; USD 140,000 - 189,000; Full time

Benefits offered by this job

Flexible work model

Remote work where possible

Job summary

Amgen is seeking a Regulatory Writing Senior Manager to lead the regulatory writing activities for complex product submissions and act as the functional area lead on cross-functional product teams. You will mentor junior writers, supervise contractors, and oversee timelines for submissions and related documents.

Ideal candidates have extensive regulatory writing experience in biotech/pharma, strong leadership skills, and the ability to manage multiple projects under SOPs and regulatory

Qualifications

• Doctorate or equivalent with 2+ years related experience or
• Master’s with 6+ years related experience or
• Bachelor’s with 8+ years related experience or
• Associate’s with 10+ years related experience or
• High school diploma with 12+ years related experience

Responsibilities

• Lead authoring or oversight of regulatory submission documents including CSRs, IBs, and eCTD materials
• Review and approve drafted documents per SOPs
• Lead writing activities for complex submissions (NDA/BLAs) with limited supervision
• Serve as functional area lead on product teams and provide input for Global Regulatory Plans
• Supervise contract/freelance writers and mentor junior medical writers
• Drive departmental and cross-departmental initiatives and timelines

Skills

Regulatory writing leadership

Mentoring

Cross-functional collaboration

Regulatory submissions

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

eCTD knowledge

Job description

Regulatory Writing Senior Manager

Career Category: Regulatory

At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.

What you will do

In this key 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

Basic Qualifications

• Doctorate degree and 2 years of directly related experience; OR
• Master’s degree and 6 years of directly related experience; OR
• Bachelor’s degree and 8 years of directly related experience; OR
• Associate’s degree and 10 years of directly related experience; OR
• High school diploma / GED and 12 years of directly related experience

Preferred Qualifications

• Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
• 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

What you can expect of us

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program
• 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

Salary Range

139,581.90 USD - 188,846.10 USD

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.