Regulatory Writing Manager, NB50205272 - South San Francisco, CA

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com We are seeking talented individuals to help bring our products to those in need.This is an opportunity for a Manager position in Amgen's Global Regulatory Writing group. The purpose of this position is to prepare scientific and regulatory documents that comply with global regulatory standards.This position could also be performed from another Amgen office or from a home-based location.Key responsibilities include:- Independently writes clinical study reports, Investigator Brochures, Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, Risk Management Plans, safety narratives, and other regulatory documents- Participates in document development for FIH studies- Write and supervise the preparation of the clinical portions of Modules 2 and 5 for CTD regulatory submissions- Assists in preparation of other regulatory documents (eg, Responses to regulatory agency questions, protocols, statistical analysis plans)- Formal review and approval of regulatory documents (stage 1, 2, and 3 management review)- Functional area representative on regulatory and clinical project teams- Provide functional area input for Global Regulatory Plan, Global Development Plan, and team goals- Participate in the development of study timelines for regulatory documents- Provides input into regulatory submission strategy- Work with contractors, freelance, and CRO writers- Participates in training and mentoring of junior medical writers- Participate in departmental and cross-departmental initiatives, as appropriate- Keep abreast of professional information and technology through literature, symposia, and conferencesBasic Qualifications:- Bachelors degree (scientific discipline) and 5+ years Biotech/Pharmaceutical experiencePreferred Qualifications:- Masters degree and 3+ years Biotech/Pharmaceutical experience- Doctoral degree and 1+ years Biotech/Pharmaceutical experience- Experience in medical or scientific writing, 5+ years of medical writing experience in an industry setting Amgen is the leading human therapeutics company in the biotechnology industry. Our mission is to serve patients. We foster a culture of innovation, using our expertise in advanced science and technology to find new and better medicines to fight serious illness. For more information about Amgen, our visionary science, and our powerful medicines, visit: www.amgen.com Company: Amgen SF LLC Location: South San Francisco, CA 94080 Job Category: Business/Strategic Management Reference Code: 50205272