Associate Regulatory Writing

7 days ago

Hyderabad, Telangana, India Amgen Full time ₹ 8,00,000 - ₹ 12,00,000 per year
Career CategoryRegulatoryJob Description

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 the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.

Roles & Responsibilities:

  • Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
  • Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
  • Collaborate with team members to resolve problems and escalate issues
  • Record and maintain written redaction strategy for the study and product
  • Manage timelines and coordinate work across team
  • Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
  •  Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
  • Assist/support trial disclosure audits and inspections
  •  Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
  • Generate /manage reports, trackers, portals and metric activities

Required Skills:

  • Experience understanding and interpreting data/information and its practical application
  • Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
  • Ability to follow controlled processes
  • Excellent spoken and written English
  • Project management skills, including ability to prioritize work in order to meet required deadlines
  • Problem solving ability

Basic Qualifications:

  • Bachelor's degree
  • Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
  • Familiarity with clinical research and clinical regulatory documents
  • Knowledge of clinical trial disclosure regulations, guidelines, and best practices

Preferred Qualifications:

  • > One year experience preparing regulatory documents for public disclosure
  • Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), , EudraCT, EU CTIS, and other registries
  • Familiarity with redaction/anonymization of clinical trial documents

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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 an accommodation.

.

  • Associate, Regulatory Writing

    3 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionRoles 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- Ensures theconsistencyandaccuracyof layouts, fonts, margins, styles, and spacing, logical content organization, and proper use of headings,...

  • Director Global Regulatory Writing

    3 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionIt is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.- Prepare and oversee the review and approval of...

  • Global Regulatory Writing Manager

    3 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionRoles & Responsibilities:- Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric...

  • Sr Associate Regulatory Writing

    7 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 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...

  • Urgent Search) Regulatory Writing Mgr

    3 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionIn this vital role, you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To 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)...

  • 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...

  • Regulatory Affairs CMC Associate

    2 weeks ago

    Hyderabad, Telangana, India Ztek Consulting Full time

    Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...

  • Regulatory Affairs CMC Associate

    2 weeks ago

    Hyderabad, Telangana, India Ztek Consulting Full time

    Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...

  • Regulatory Affairs Sr Associate

    1 week ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure...

  • Regulatory Affairs Sr Associate

    1 week ago

    Hyderabad, Telangana, India Amgen Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable...