Global Scientific & Regulatory Documentation Lead

Bristol-Myers Squibb; Warszawa; Hybrid; PLN 230.560 - 279.377; Vollzeit

Benefits dieser Stelle

Hybrid work model

Stock options

Zusammenfassung

Bristol Myers Squibb is seeking a Senior Manager, Global Scientific and Regulatory Documentation in Warsaw. You will lead authoring of regulatory documents supporting submissions and approvals, coordinating scientific, medical, and regulatory input from cross-functional teams.

Requires PharmD/PhD or Master’s/Bachelor’s in a relevant field and 5 years in regulatory documentation. Hybrid work with at least 50% onsite in Warsaw; on-site at local BMS facility. Compensation and career growth offered.

Qualifikationen

• PharmD/PhD in a relevant scientific discipline or Masters/Bachelor's degree.
• 5 years of pharmaceutical regulatory documentation.
• Strong writing skills in authoring and managing production of IB, CSR, Protocols.
• Ability to analyze complex data from diverse scientific disciplines.
• Knowledge of global drug development and regulatory documentation requirements.
• Ability to manage timelines and quality in cross-functional teams.
• Working knowledge of a document management system and publishing process.

Aufgaben

• Author complex regulatory documents (IBs, Protocols, CSR, briefing docs, CTD summaries) for regulatory submissions.
• Use document development tools with AI and publishing features to improve efficiency and quality.
• Participate in document subteams and manage timelines for components.
• Join strategy sessions to align messaging, flow, and consistency of documents.
• Develop document prototypes and shells; maintain prototypes for projects.
• Ensure compliance with processes; resolve issues with cross-functional team members.
• Review and edit documents as required.
• Serve as liaison for external documentation support and ensure standards are met.
• Lead and influence a diverse group of authors without a direct reporting line.

Kenntnisse

Strong writing

Regulatory docs

Timeline management

Cross-functional work

Document management system

Regulatory submissions

Ausbildung

PharmD/PhD or Master/Bachelor

Jobbeschreibung

Bristol Myers Squibb is seeking a Senior Manager, Global Scientific and Regulatory Documentation in Warsaw. You will lead authoring of regulatory documents supporting submissions and approvals, coordinating scientific, medical, and regulatory input from cross-functional teams.

Requires PharmD/PhD or Master’s/Bachelor’s in a relevant field and 5 years in regulatory documentation. Hybrid work with at least 50% onsite in Warsaw; on-site at local BMS facility. Compensation and career growth offered.