Regulatory Writing Sr Mgr

BioSpace; Washington (District of Columbia); On-site; USD 180,000 - 230,000; Full time

Job summary

Amgen is seeking a Regulatory Writing Senior Manager to lead writing activities for complex product submissions and to mentor junior writers. You will oversee the authoring of critical regulatory documents and supervise contract staff, ensuring SOP-compliant, high-quality deliverables.

You will serve as a functional area lead on cross-functional product teams and drive timelines and regulatory strategy while contributing to Global Regulatory Plans and team goals.

Qualifications

• Doctorate degree and 2 years of directly related experience OR Masters degree and 6 years of directly related experience OR Bachelors degree and 8 years of directly related experience OR Associates degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience.

Responsibilities

• Author or oversee the authoring of regulatory submission documents including CSRs, IBs, responses to questions, Protocols, ICFs, and Pediatric Investigation Plans.
• Conduct formal review and approval of authored documents following SOPs.
• Lead regulatory writing activities for complex product submissions (new and supplemental drug/biologics license applications).
• Serve as functional area lead on product teams (GRLT, Evidence Generation Team, Global Safety Team, Label Working Group).
• Provide functional area input for Global Regulatory Plan and team goals.
• Supervise contract and freelance writers and mentor junior medical writers.
• Lead departmental and cross-departmental initiatives and generate document timelines.

Skills

Regulatory writing

Leadership

Mentoring

Cross-functional collaboration

Project coordination

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Job description

HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Regulatory Writing Senior ManagerLive
What You Will Do
Lets do this. Lets 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

WinWhat We Expect Of YouWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications
Doctorate degree and 2 years of directly related experience
OR
Masters degree and 6 years of directly related experience
OR
Bachelors degree and 8 years of directly related experience
OR
Associates degree and 10 years of directly related experience
Or
High school diploma / GED and 12 years of directly related experience
Preferred Qualifications
ThriveWhat You Can Expect Of UsAs 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.
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, 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

Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.
careers.amgen.comApplication 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.