Manager – Standards Medical Writer (Biomedical Data Stewardship)
By Admin · Medical & Scientific Writing
ROLE OVERVIEW
Amgen is expanding its global Biomedical Data Stewardship (BMDS) capabilities in India, and this Manager, Standards Medical Writer role sits at the intersection of medical writing, clinical data standards, and regulatory governance. Based in Hyderabad, the position supports Amgen's Center for Design & Analysis by advancing protocol standards, structured authoring, and metadata repository (MDR) execution. The role is critical to ensuring protocols are fit-for-purpose, inspection-ready, and aligned with global clinical development strategy across therapeutic areas. By partnering with Global Regulatory Writing, Clinical Development, Regulatory, and TA SMEs, the writer-manager helps harmonize protocol language, govern libraries, and improve data quality from authoring through submission. This is a compelling opportunity for life-sciences professionals seeking global cross-functional exposure, influence over enterprise standards, and a career path in medical writing, clinical data governance, or regulatory operations within a top-tier biopharma.
ROLE DEFINITION & RESPONSIBILITIES
- •Collaborate closely with global BMDS leadership and cross-functional partners to align India-based execution with enterprise standards strategy.
- •Provide deep subject matter expertise in protocol standards, structured authoring, and library implementation across multiple therapeutic areas.
- •Partner closely with Global Regulatory Writing, Clinical Development, Regulatory Affairs, and TA SMEs to align governed standards with protocol authoring practices.
- •Support impact assessments, change control documentation, stakeholder communication, and implementation planning for library updates.
- •Review clinical protocols for compliance with appropriate protocol libraries and provide clear, actionable feedback to study teams.
- •Perform metadata repository (MDR) entry across protocol, data collection, SDTM, and SAP; validate outputs and remediate errors.
- •Develop and maintain implementation guides, governance documents, job aids, controlled documents, and MDR QC reports.
- •Identify and champion process automation and technology improvements for protocol authoring governance and compliance.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree or higher in life sciences, computer science, statistics/biostatistics, programming, business administration, or related discipline; or equivalent education and experience.
- 2+ years of knowledge/experience in the Pharmaceutical/Biotech industry.
- 2+ years leading implementation of clinical data standards in a regulated environment.
- Experience in medical or regulatory writing, including protocol authoring and/or metadata repository (MDR) systems.
- Willingness to learn MDR structures and underlying data tables; MDR experience is helpful but not mandatory.
- Working knowledge of drug development lifecycle, ICH-GCP, and global regulatory expectations for protocol content.
- Demonstrated ability to work with global cross-functional teams and influence decision-making.
PREFERRED QUALIFICATIONS
- •Master's or PhD in Life Sciences, Biostatistics, or Computer Science
- •Drug Development Experience (Early/Late Phase, Observational Studies)
- •Project Management (PMP, Agile, or Lean Six Sigma)
- •Policy/SOP Development & External Industry Committee Participation
- •Experience with CDISC, SDTM, or Define-XML
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.