Associate Director, Global Regulatory Writing

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.



What you will do
Lets do this. Lets change the world. In this vital role you will will develop and oversee key clinical/regulatory documents ensuring clinical data is presented objectively, clearly, and concisely in compliance with International Council on Harmonisation (ICH) guidelines and global regulatory requirements. Collaborate with Product Teams and other functional leads to develop submission strategy and support consistent messaging within and across programs. Maintain key business relationships with cross-functional Product Teams and management across R&D. Serve as functional area lead on Product Teams, and lead writing activities for complex global submissions providing scientific and regulatory expertise, and technical and team leadership.




Key Responsibilities:

Lead the regulatory writing activities required for complex product submissions, including original and supplemental New Drug Applications and Biologics License Applications, as well as for clinical documents required for Investigational New Drug Applications and Clinical Trial Applications.

Develop and oversee the authoring, formal review, and approval of key clinical and regulatory documents ensuring clinical data is presented objectively, clearly, and concisely in compliance with ICH guidelines and global regulatory requirements, including:Protocols, Protocol Amendments, Informed Consent Forms, Plain Language Protocol Synopses, Investigator Brochures, Clinical Study Reports, Plain Language Summaries, electronic Common Technical Document Module 2 Clinical Summary Documents, Module 5.2 Table of All Studies, Clinical Overview Addenda, Responses to Questions, Briefing Documents, Pediatric Investigation Plans, Priority Review Requests, Breakthrough Designation Requests, Orphan Drug Designation Requests, and other regulatory documents.

Manage regulatory medical writers, as assigned, including career development, performance reviews, and ongoing coaching and guidance; serve as a role model for Amgen values and leadership attributes.

Effectively prioritize and manage work and balance internal deliverables with outsourcing needs such that all writing deliverables are achieved in accordance with project timelines.

Serve as functional area lead on Product Teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group):

Guide and advise senior professionals across product teams and GRW; support development of submission plans and strategy and consistent messaging within and across programs.

Provide scientific, technical, and regulatory expertise for Global Regulatory Plan and team goals.

Oversee resource allocation for Product Teams, ensuring delivery of projects/programs in an effective and timely manner.

Develop, align, and track project timelines and assignments to meet overall objectives.

(Co)Lead cross-functional teams for internal and external projects.

Participate in Amgen cross-functional process improvement initiatives, including contributing to process development, defining training requirements, developing training programs, guidance documents, and work instruction manuals, as appropriate.

Design and develop methods, techniques, and processes for output creation, through departmental and cross-departmental initiatives, as appropriate.

Integrate trends, data, and information into plans, deliverables, and recommendations.

Partner in departmental goal planning, development, execution, and reporting

In conjunction with GRW Directors, manage and implement day-to-day departmental operations, including hiring, resourcing projects, generating department metrics and resource projections, and resolving process issues, etc.

Support GRW Directors on resource, project and budget planning, and other departmental management activities.

Knowledge and Skills:

Ability to independently analyze scientific data and interpret its significance in practical applications.

Excellent written/oral communication skills and attention to detail.

Highly skilled in word processing and other Microsoft Office programs.

Advanced knowledge of scientific/technical writing and editing and overall clinical development process for new compounds.

Advanced disciplinary and basic industry knowledge.

Must demonstrate strong leadership skills in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment.

Ability to understand, follow, and develop complex standard operating procedures, guidance documents, and work instructions.

In-depth understanding of project management techniques, beginning understanding of business and country interdependencies.

In-depth understanding of company goals and competitor practices in relation to area of expertise.

Self-starter with a drive and perseverance to achieve results and motivate others.

What we expect of you

Masters degree and 10 to 14 years of regulatory writing experience OR

Bachelors degree and 14 to 16 years of regulatory writing experience OR

Diploma and 18 to 20 years of regulatory writing experience

3 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Preferred Qualifications:

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

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

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

Advanced knowledge of document management systems.

Expert knowledge and understanding of International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidances and requirements relevant to regulatory submissions.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.