EG-140 - Regulatory Affairs / Medical Writing

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Summary To coordinate and author complex regulatory documents needed for regulatory submissions ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members for assets in the immunology and cardiovascular therapeutic areas. Implements regulatory documentation standards that support speedand consistency of regulatory submissions across all full development / life cycle management assets and geographies.

Author complex clinical documents needed for regulatory submissions (eg, Pivotal Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, Investigator’s Brochures, HA Briefing Books, responses to Health Authority queries) for timely submission to health authorities worldwide according to: good documentation principles (organization, clarity, scientific standards) consistency between text and tabular presentations or graphical displays in compliance with BMS documentation standards and regulatory requirements Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents. Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects. Prepare document prototypes, including the document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. Lead or co-lead (with Documentation Lead) teams to define content and organization for complex documents (eg CTD summary documents).  Comply with internal processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure: optimal communication between authoring team and development team members coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation timely completion and high quality of assigned documents Review regulatory and clinical documentation according to good documentation practices (organization, clarity, scientific standards), to establish consistency of content within TA and asset, and compliance with BMS documentation standards and worldwide regulatory requirements. Facilitate proactive sharing of knowledge and key learnings within the group and across other functions. Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship. Qualifications & Experience PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered. Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans). Analyze and interpret complex data from a broad