Regulatory Writing Mgr

10-12 years

Not Disclosed

Hyderabad

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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: Regulatory Medical Writer
Company: Amgen
Location: [Location not specified]

About Amgen:

At Amgen, our mission is to serve patients living with serious illnesses, and we have been pioneering biotechnology solutions since 1980. Focused on oncology, inflammation, general medicine, and rare diseases, we help millions of patients worldwide. Joining the Amgen team means contributing to transformative work that improves the lives of patients and reshapes the future of medicine.

Our culture is award-winning—collaborative, innovative, and science-driven. If you thrive on challenges, Amgen is the place for you to grow your career while making a significant impact.

What You Will Do:

In this vital role, you will author and gain approval for scientific and regulatory submission documents, ensuring alignment with global regulatory standards. You will maintain key business relationships across cross-functional product teams and may serve as a functional area lead for product teams. You will also manage writing activities for product submissions, train and mentor junior writers, and assist with departmental activities.

Roles & Responsibilities:

Author regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Informed Consent Forms, and other regulatory documents.
Conduct formal reviews and approvals of authored documents following standard operating procedures.
Manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications.
Serve as a functional area lead on product teams such as Global Regulatory Team, Evidence Generation Team, and others.
Contribute to the development of the Global Regulatory Plan and team goals.
Collaborate with contract and freelance writers as needed.
Train and mentor junior medical writers.
Participate in cross-departmental initiatives.
Generate document timelines in collaboration with the team.
Stay up-to-date with relevant professional information and technology.

What We Expect of You:

At Amgen, we value diverse contributions to serve patients, and we’re looking for individuals who bring unique skills and perspectives.

Basic Qualifications:

Doctorate degree, 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 Qualifications:

Functional Skills:
- Proficiency in Microsoft Office and word processing.
- Significant knowledge of scientific/technical writing and the clinical development process for new compounds.
- Ability to understand and follow complex standard operating procedures (SOPs), guidance documents, and work instructions.
- Strong knowledge of ICH and GCP guidelines and requirements.
Soft Skills:
- Excellent written and oral communication skills with attention to detail.
- Leadership in team environments, requiring negotiation, persuasion, and collaboration.
- Proficient time and project management skills.
- Self-starter with the drive to achieve results.

Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer, committed to creating an inclusive environment. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. We provide reasonable accommodations for individuals with disabilities during the job application or interview process and ensure they have equal access to benefits and privileges of employment.

What You Can Expect From Us:

Amgen is committed to your growth, offering competitive benefits and a supportive, collaborative culture. We’ll support your professional and personal journey every step of the way with our competitive Total Rewards Plans aligned with industry standards.

Apply Now:

For a career that defies imagination, join Amgen. Careers at Amgen

Transform lives, including your own, at Amgen.

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Regulatory Writing Mgr

Job Description

About Amgen:

What You Will Do:

What We Expect of You:

Equal Opportunity Statement:

What You Can Expect From Us:

Apply Now:

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