Regulatory Writing Sr Mgr

Biopharma Careers; United States; Hybrid; USD 140,000 - 189,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision insurance

Life and disability insurance

Flexible spending accounts

Bonus program

Stock-based incentives

Generous time-off

Job summary

Amgen in the United States is seeking a Regulatory Writing Senior Manager to lead the regulatory writing strategy for product submissions. You will serve as the functional area lead on product teams, supervise authors, and mentor junior writers while coordinating with global regulatory teams.

The role concentrates on complex submissions such as Clinical Study Reports, eCTD Module 2 documents, and labelling additions.

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.
• Demonstrated leadership of cross-functional teams.

Responsibilities

• Lead writing activities for complex product submissions and provide expertise to product teams.
• Oversee authoring and approval of regulatory documents (e.g., CSRs, IBs, eCTD modules).
• Mentor junior medical writers and supervise contractors.
• Coordinate with Global Regulatory Teams and other functions.
• Generate and manage document timelines.

Skills

Regulatory writing

Biotech/pharma experience

Leadership

Education

Doctorate

Master's

Bachelor's

Associate

High school diploma

Job description

Career Category

Regulatory

Regulatory Writing Senior Manager

Job Description

What you will do

Let’s do this. Let’s change the world. 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

What we expect of you

The dynamic professional we seek is a leader with these qualifications.

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

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well‑being.

Benefits and Perks

• 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, or for field sales representatives, a sales-based incentive plan
• 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

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.

Equal Opportunity Employer

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.

Salary Range 139,581.90USD -188,846.10 USD