Associate, Regulatory Writing

3 days ago

Hyderabad Telangana, India Amgen Full time

**India - Hyderabad**

**JOB ID**:
R-210832

**LOCATION**:

- India - Hyderabad

**WORK LOCATION TYPE**:
On Site

**DATE POSTED**:
Apr. 03, 2025

**CATEGORY**:
Regulatory

**Roles and Responsibilities**
- ** Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) to ensure submission readiness quality**:

- Coordinates document collection with cross-functional team members and ensures publishing readiness of the documents
- Participates in collaborative team activities for noncomplex documents, including support to collect input from authors/reviewers
- Participates in the cross-functional document review process
- Participates in project management activities, i.e., timeline tracking and scheduling meetings with team members
- Learns and uses organizationally required authoring tools and technology platforms
- Attends cross-functional meetings with writers and departments, as appropriate, to share and gather information relevant for successful completion of assigned documents
- ** Documents in scope include,** but are not limited to: Clinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator’s Brochures, local Risk Management Plans, noncomplex Original Protocols/ Protocol Amendments, Plain Language Protocol Summaries, and Informed Consent Forms
- Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides
- Compiles and maintains product-specific reference libraries across therapeutic areas

**Basic Qualifications**
- **Graduated with a Bachelor’s degree in science from an accredited college or university**:
**Preferred Qualifications**
- ** 1-2 years of experience formatting, performing QC reviews, and managing the coordination of regulatory/clinical documents at a pharma/biotech or similar organization**:

- Some scientific or medical knowledge
- Some exposure to basic statistical and medical communication principles
- Strong oral and written communication skills
- Able to collaborate with others and build solid and positive relationships with cross‐functional team members
- Able to work independently and problem solve
- Attention to detail and accuracy
- Organizational skills in time and project management, including ability to manage multiple projects simultaneously

  • Associate Regulatory Writing

    7 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...

  • Global Regulatory Writing Manager

    1 week ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Career CategoryRegulatoryJob DescriptionCareer Category: RegulatoryJob DescriptionLet's do this. Let's change the world. In this vital role you will 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...

  • Regulatory Data

    3 days ago

    Hyderabad, Telangana, India Amgen Full time

    **India - Hyderabad** **JOB ID**: R-208732 **LOCATION**: - India - Hyderabad **WORK LOCATION TYPE**: On Site **DATE POSTED**: Mar. 14, 2025 **CATEGORY**: Regulatory Roles & Responsibilities: - Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory...

  • Regulatory Data

    3 days ago

    Hyderabad, Telangana, India Amgen Full time

    **India - Hyderabad** **JOB ID**: R-206528 **LOCATION**: - India - Hyderabad **WORK LOCATION TYPE**: On Site **DATE POSTED**: Feb. 17, 2025 **CATEGORY**: Regulatory Roles & Responsibilities: - Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory...

  • Regulatory Affairs Associate

    7 days ago

    Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time

    CTD Dossier Drafting (Modules 2, 3, 4) - Regulatory writing - Clinical Regulatory & Pharmacovigilance Regulatory - Regulatory commitment & compliance - Any other Regulatory activities on need basis - Support Line manager & Matrix manager in Regulatory projects - Coordination and interaction with cross-functional teams Mandatory Skills Effective...

  • Sr Associate Regulatory Writing

    7 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...

  • Manager, Global Regulatory Writing

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Join Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic...

  • Manager, Global Regulatory Writing

    3 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Career CategoryRegulatoryJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest...

  • ▷ Apply Now: Sr Associate Regulatory Affairs

    3 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category Regulatory ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases and make people s lives easier fuller and longer We discover develop manufacture and deliver innovative medicines to help millions of patients Amgen helped establish the biotechnology industry more than 40 years ago and remains on...

  • ▷ (3 Days Left) Global Heor Value Writing Senior Associate

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category Health Economics Global HEOR Value Writing Senior Associate Department Global Health Economics Outcomes Research HEOR Job Family Health Economics Job Type Full-Time Location Hyderabad India Reports To Global Value Writing Team Lead Position Summary The Global HEOR Value Writing Senior Associate plays a critical role in supporting Amgen s...