Manager - Standards Medical Writer (Biomedical Data Stewardship)

Job description

Career Category Scientific Job Description Manager, Biomedical Data Stewardship (India) What you will do Amgen is expanding its global Biomedical Data Stewardship (BMDS) capabilities, with Amgen India (AIN) playing an increasingly critical role in integrated delivery and functional leadership. As Manager, Biomedical Data Stewardship, you will help advance Amgen’s Protocol standards and support MDR needs through India-based execution while partnering closely with global BMDS and cross-functional teams. You will act in support of the Design & Innovation function within the Center for Design & Analysis. This position combines hands-on technical depth and cross-functional collaboration to ensure data standards are fit-for-purpose, inspection-ready, and aligned with Amgen’s global clinical development strategy. Responsibilities: This role supports global Biomedical Data Stewardship objectives through India-based execution and cross-functional collaboration. Collaborate with global BMDS leadership and cross-functional partners to ensure alignment with enterprise standards strategy. Provide subject matter expertise in protocol standards, structured authoring, and library implementation to ensure consistent and compliant protocol development across therapeutic areas. Collaborate cross-functionally with Global Regulatory Writing (GRW), Clinical Development, Regulatory, TA SMEs, Dev IS, and other stakeholders to ensure alignment between governed standards and protocol authoring practices. Support and champion impact assessments, change control documentation, stakeholder communication, and implementation planning for library updates. Liaise with cross-functional teams to ensure consistent and timely implementation of approved libraries across studies and programs. Review protocols to ensure compliance with appropriate protocol libraries; provide feedback and guidance to study teams. Support development and maintenance of implementation guides, governance documentation, job aids, and controlled documents related to protocol standards. Support metadata repository (MDR) entry across multiple functional areas (protocol, data collection, SDTM, SAP). Validate MDR entry success through output review; diagnose and remediate errors when outputs fail. Support the development and maintenance of MDR QC reports to monitor data entry quality and output success. Provide DES expertise to stakeholders across R&D ensuring alignment across functions. Develop and maintain strong working relationships with key stakeholders. Identify and champion opportunities to improve efficiency and compliance via improved technological solutions, including process automation within protocol authoring governance. Adhere to all Amgen Policies, SOPs and other controlled documents when developing, maintaining, and governing data standards. Skills/Knowledge: Data Standards & Technical Expertise Strong experience in medical or regulatory writing, including protocol authoring and/or MDR systems. Experience implementing and governing structured authoring templates and standardized protocol language. Experience working with structured document platforms (eg, Smart Template) and/or metadata-driven content governance. MDR experience is not necessary but must have a willingness to learn the MDR and underlying data tables. Collaboration & Communication Experience working in collaboration with global cross-functional teams with demonstrated effective communication skills (written and oral) and ability to influence decision making Experience developing documentation writing, training, and compliance Process & Governance Working knowledge of regulatory requirements and inspection readiness expectations related to clinical protocols. Knowledge of standards governance processes including versioning, impact analysis, documentation, approval workflows, and audit readiness. Understanding of the end-to-end drug development lifecycle and global regulatory expectations for protocol content. This position is currently located at Amgen India (Hyderabad). What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Bachelor’s degree or higher in computer science, statistics/biostatistics, programming, life science, business administration, or related discipline, or equivalent combination of education and experience 2+ years knowledge/experience in the Pharmaceutical/Biotech industry 2+ years experience of leading the implementation of clinical data standards in a regulated environment Preferred Qualifications Master’s degree or higher in computer science, statistics/biostatistics, programming, life science, or related discipline 2+ years experience leading implementation of Protocol standards in a regulated Clinical Development setting Drug Development experience (pre-, early, late phase and/or observational studies) in related industries or academic research Experience in protocol development across early and/or late phase clinical studies Experience supporting cross-functional governance initiatives Project planning and management experience Process improvement and operational effectiveness leadership Development of policies and SOPs External visibility (industry committees/forums) Demonstrated effective communication skills (written and oral) What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and develop within our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits .