Regulatory Writer

1 week ago

Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Sr Associate Regulatory Writing

Career CategoryRegulatory Job 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, or prepare documents for public registries e.g.
  • Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
  • Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
  • Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues
  • Record and maintain written redaction strategy for the study and product
  • Support trend analysis and process improvement
  • Execute clinical trial disclosure business process and ensure
  • delivery in compliance with regulations, Amgen's 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
  • Ability to communicate and negotiate to influence stakeholders
  • Project management skills, including ability to prioritize work in order to meet required deadlines
  • Problem solving ability

Basic Qualifications:

  • Bachelor's degree
  • Minimum of 2 years experience in preparing regulatory documents for public disclosure
  • Understanding of clinical research and clinical regulatory documents
  • Working knowledge of clinical trial disclosure regulations, guidelines, and best practices

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.

. Experience LevelMid Level

  • Scientific / Regulatory Content Writer

    2 weeks ago

    Hyderabad, Telangana, India, Telangana ArtiXio Full time

    About the Role We are seeking a Scientific / Regulatory Content Writer with 4–7 years of proven experience in developing high-quality content in the scientific, medical, or regulatory domains. The ideal candidate will have exceptional writing skills, a keen eye for detail, and the ability to transform complex topics into clear, engaging, and evidence-based...

  • Regulatory Writer

    1 week ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Associate Regulatory Writing Career CategoryRegulatory Job 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...

  • Content Writer

    2 weeks ago

    Hyderabad, Telangana, India Unicon Pharma Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesUnicon Pharma is looking for a talented Content Writer with excellent communication skills and a strong interest or background in the pharmaceutical or life sciences domain. The role involves creating clear, accurate, and engaging content for social media platforms, blogs, newsletters, marketing materials, and internal communications....

  • Medical Writer

    5 days ago

    Hyderabad, Telangana, India Valuelabs Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job descriptionThe Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions.Roles & Responsibilities:Draft, review, and finalize clinical study protocols, investigator brochures, informed consent forms, and clinical study reports (CSRs).Prepare...

  • Medical Writer

    5 days ago

    Hyderabad, Telangana, India ValueLabs Full time ₹ 2,50,000 - ₹ 7,50,000 per year

    Job descriptionThe Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions.Experience : 1+ yearsLocation : Hyderabad (Work from office)Roles & Responsibilities:Draft, review, and finalize clinical study protocols, investigator brochures, informed...

  • Global Regulatory Writing Manager

    2 weeks ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time

    Manager, Global Regulatory Writing Career CategoryRegulatory Job Description Join 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...

  • Manager, Global Regulatory Writing

    2 weeks 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...

  • Medical Writer

    4 weeks ago

    Hyderabad, Telangana, India, Telangana ValueLabs Full time

    Job descriptionThe Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions.Experience : 1+ yearsLocation : Hyderabad (Work from office)Roles & Responsibilities:Draft, review, and finalize clinical study protocols, investigator brochures, informed...

  • Team Lead

    5 days ago

    Hyderabad, Telangana, India Writer Corporation Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Roles and ResponsibilitiesManage daily operations of the team, ensuring efficient call handling and customer satisfaction.Monitor shrinkage rates and implement strategies to reduce attrition within the team.Handle grievances and escalate issues promptly to senior management when necessary.Ensure compliance with company policies, procedures, and regulatory...

  • Senior Medical Writer II

    2 weeks ago

    Hyderabad, Telangana, India ProPharma Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...