Regulatory Writing Mgr

10-12 years

Not Disclosed

Hyderabad

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Regulatory Writing Manager

Department: Global Regulatory Affairs & Strategy (GRAAS)
Location: Not specified
Hiring Manager: Jennifer Vande Weghe
Role GCF: 5

About Amgen:

Amgen is a global biotechnology leader committed to discovering, developing, manufacturing, and delivering innovative medicines that help millions of patients around the world. With over 40 years of pioneering work in biotechnology, Amgen continues to push the boundaries of what’s possible using technology and human genetic data to fight the world’s toughest diseases.

Role Overview:

The Global Regulatory Writing Manager will be responsible for authoring and managing the approval process for scientific and regulatory submission documents that meet global regulatory standards. This role involves collaborating with cross-functional teams, serving as the functional lead on product teams, and mentoring junior writers. The individual will ensure that Amgen's submissions adhere to regulatory guidelines while driving successful product development.

Key Responsibilities:

Regulatory Document Authoring:
Write and gain approval for various regulatory documents, including Clinical Study Reports, Investigator Brochures, Clinical Protocols, Informed Consent Forms, Clinical Summaries, Pediatric Investigation Plans, and more.
Document Review & Approval:
Conduct formal reviews of authored documents, ensuring adherence to standard operating procedures and regulatory requirements.
Product Submission Management:
Manage writing activities for product submissions, including new and supplemental drug applications and biologics license applications.
Team Leadership & Collaboration:
Serve as the functional lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team), contributing to the Global Regulatory Plan and team goals.
Mentoring & Training:
Provide mentorship and guidance to junior writers, and assist in training new members of the team.
Project & Time Management:
Generate document timelines and manage multiple writing activities, ensuring they are completed within the stipulated deadlines.
Continual Learning & Development:
Stay updated with relevant professional information and emerging technologies within the regulatory writing field.

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:
- 5+ years in medical writing in the biotech/pharmaceutical industry.
- Previous experience with regulatory documents in Regulatory Affairs, Research, or Development.

Preferred Skills:

Proficiency:
Strong experience with Microsoft Office and word processing tools.
Regulatory Knowledge:
In-depth knowledge of ICH (International Council on Harmonization) and GCP (Good Clinical Practice) guidelines.
Leadership Skills:
Ability to demonstrate leadership and negotiate with cross-functional teams to achieve results.
Time Management:
Proficient in managing multiple projects and adhering to deadlines.

Soft Skills:

Excellent written and oral communication.
Attention to detail and ability to manage complex document reviews.
Strong project management and organizational skills.
Ability to work autonomously and collaborate effectively within teams.

What You Can Expect from Us:

Amgen offers a collaborative work culture, competitive benefits, and an opportunity to make a meaningful impact on patient care. With a focus on continuous learning and development, Amgen supports the growth of its employees while advancing groundbreaking scientific discoveries.

Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other characteristic protected by law. Amgen also provides reasonable accommodation for individuals with disabilities during the job application or interview process.

To apply, visit careers.amgen.com

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Regulatory Writing Mgr

Job Description

Job Title: Global Regulatory Writing Manager

About Amgen:

Role Overview:

Key Responsibilities:

Basic Qualifications:

Preferred Skills:

Soft Skills:

What You Can Expect from Us:

Equal Opportunity Statement:

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