Regulatory Writing Sr Mgr

BioSpace; Washington (District of Columbia); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health and welfare plans

Bonuses and incentives

Stock-based incentives

Flexible time off and work models

Job summary

Amgen is seeking a Regulatory Writing Senior Manager in the Washington, DC area. You will lead writing activities for complex submissions, supervise contract writers, and mentor junior staff.

In this role, you will coordinate with cross-functional teams to ensure timely, compliant documentation and contribute to strategic regulatory plans, while guiding departmental initiatives and timelines.

Qualifications

• Doctorate degree with related experience or advanced degrees with substantial relevant experience.
• Masters with 6+ years related experience or Bachelor with 8+ years.
• Associates with 10 years related experience or high school with 12 years of related experience.

Responsibilities

• Lead writing activities for complex product submissions and serve as functional area lead on product teams.
• Supervise contract and freelance writers and mentor junior medical writers.
• Generate document timelines and ensure regulatory documents meet SOPs and quality standards.
• Provide input for Global Regulatory Plan and team goals.

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma / GED

Job description

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.

Regulatory Writing Senior Manager

Live

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

We 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

• 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.

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

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.