Global Regulatory Writing Manager

12+ years

Not Disclosed

Hyderabad

10 Jan. 18, 2025

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

Global Regulatory Writing Manager
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Jan. 10, 2025
Job ID: R-203635

Career Category: Regulatory

Job Description

Let’s do this. Let’s change the world. In this vital role, you will foster key business relationships with cross-functional product team members, lead writing activities for regulatory submissions, train and mentor junior writers, and support departmental initiatives.

Roles & Responsibilities

Author regulatory submission documents, including:
- Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Informed Consent Forms, and other regulatory documents.
- Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans.
Conduct formal reviews and approvals of documents as per SOPs.
Manage writing activities for product submissions, including new and supplemental drug/biologics license applications, with supervision.
Serve as the functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Label Working Group).
Provide functional input for Global Regulatory Plans and team objectives.
Collaborate with contract and freelance writers.
Train and mentor junior medical writers.
Participate in departmental and cross-departmental initiatives.
Generate and manage document timelines with team collaboration.

Basic Qualifications

Doctorate degree OR
Master’s degree with 4–6 years of directly related experience OR
Bachelor’s degree with 6–8 years of directly related experience OR
Diploma with 10–12 years of directly related experience.

Preferred Qualifications

Functional Skills:

Proficiency in Microsoft Office programs.
Strong expertise in scientific/technical writing and editing.
Thorough understanding of clinical development processes and regulatory requirements.
Familiarity with ICH guidelines and Good Clinical Practice (GCP).

Soft Skills:

Excellent written and oral communication with attention to detail.
Leadership abilities in team environments requiring negotiation, persuasion, and collaboration.
Strong time and project management skills.
Self-driven with perseverance to achieve results.

What You Can Expect from Us

At Amgen, we are committed to nurturing your professional growth and well-being. Alongside a competitive base salary, we offer comprehensive Total Rewards Plans tailored to local industry standards.

Apply now for a career that challenges and inspires.

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Global Regulatory Writing Manager

Job Description

Career Category: Regulatory

Job Description

Roles & Responsibilities

Basic Qualifications

Preferred Qualifications

Functional Skills:

Soft Skills:

What You Can Expect from Us

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