Global Regulatory Writing Manager

About the role

Amgen is looking for a Global Regulatory Writing Manager in its Regulatory career category. You will maintain key business relationships with cross-functional product team members and, as requested, act as functional area lead on product teams. The role also involves managing writing activities for product submissions, training and mentoring junior writers and helping with departmental activities.

Key responsibilities

• Author regulatory submission documents such as 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, Pediatric Investigation Plans and others.
• Review and approve authored documents according to standard operating procedures.
• Manage regulatory writing for product submissions, including new and supplemental drug applications and biologics license applications, with considerable supervision.
• Serve as functional area lead on product teams such as the Global Regulatory Team, Evidence Generation Team, Global Safety Team and Label Working Group, and give input on the Global Regulatory Plan and team goals.
• Work with contract and freelance writers, and take part in training and mentoring junior medical writers.
• Generate document timelines with team input, keep up with professional information and technology, and join departmental and cross-departmental initiatives.

Required profile

• Basic qualification: doctorate, or master's degree with 4 to 6 years of directly related experience, or bachelor's degree with 6 to 8 years of directly related experience, or diploma with 10 to 12 years of directly related experience.
• Preferred: significant knowledge of scientific and technical writing and editing, and of the clinical development process for new compounds.
• Ability to follow complex SOPs, guidance documents and work instructions, and to apply scientific and technical principles and standards.
• Substantial knowledge of ICH and Good Clinical Practice (GCP) guidance and requirements.
• Excellent written and oral communication, attention to detail, leadership in a team, negotiation, collaboration and analytical judgment, and strong time and project management skills.

Required skills

• Proficiency with word processing and other Microsoft Office programs.
• Scientific and technical writing and editing.
• ICH and GCP knowledge.

Amgen states that it supports professional and personal growth through competitive benefits and a collaborative culture, and offers Total Rewards plans in addition to base salary.