Regulatory Writing Mgr

Global Regulatory Writing Manager

Role Name:Global Regulatory Writing Manager

Department Name:Global Regulatory Affairs & Strategy (GRAAS)

Role GCF:5

Hiring Manager Name:Jennifer Vande Weghe



ABOUT THE ROLE

Role Description:

To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities.

Roles & Responsibilities:

Author regulatory submission documents, as assigned, 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, Pediatric Investigation Plans, and other regulatory documents;

Conduct the formal review and approval of authored documents, following applicable standard operating procedures;

With considerable supervision, manage regulatory writing activities for 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)

May provide functional area input for Global Regulatory Plan and team goals

May work with contract and freelance writers

May participate in training and mentoring of junior medical writers

May participate in departmental and cross-departmental initiatives, as appropriate.

Generate document timelines, with team input

Keep abreast of relevant professional information and technology

Functional Skills:

Proficiency with word processing and other Microsoft Office Programs

Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds;

Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions;

Understanding and application of principles, concepts, theories and standards of scientific/technical field.

Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance’s and requirements.

Soft Skills:

Excellent written/oral communication skills and attention to detail

Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;

Proficient time and project management skills.

Self-starter with a drive and perseverance to achieve results

Basic Qualifications:

Doctorate degree OR

Master’s degree and 3 years of directly related experience OR

Bachelor’s degree and 5 years of directly related experience OR

Associate’s degree and 10 years of directly related experience OR

High school diploma / GED and 12 years of directly related experience

Experience with regulatory documents in Regulatory Affairs, Research, Development, or related area

5+ years experience in medical writing in the Biotech/Pharmaceutical industry

EQUAL OPPORTUNITY STATEMENT

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 with 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 an accommodation.