Amgen Inc
Regulatory Writing Senior Manager
United States - Remote · Senior · Contract
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About the role
- If you feel like you're part of something bigger, it's because you are.
- 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.
Responsibilities
- 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.
- 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)
- Lead departmental and cross-departmental initiatives, as appropriate
- Generate document timelines
Requirements
- Doctorate degree and 2 years of directly related experience
- Master's degree and 6 years of directly related experience
- Bachelor's degree and 8 years of directly related experience
- Associate's degree and 10 years of directly related experience
- High school diploma / GED and 12 years of directly related experience
Nice to have
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- What you can expect of us
- for a career that defies imagination
- Objects in your future are closer than they appear.
- careers.amgen.com
- 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.
Compensation
- 139,581.90USD -188,846.10 USD
Benefits
- Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Company info
- We are all different, yet we all use our unique contributions to serve patients.
This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.