W skrócie
- Zadania: Twórz i zarządzaj dokumentacją regulacyjną, wspierając kluczowe zatwierdzenia na całym świecie.
- Firma: Bristol Myers Squibb - firma zmieniająca życie pacjentów przez naukę.
- Benefity: Konkurencyjne wynagrodzenie, elastyczne godziny pracy i możliwości rozwoju zawodowego.
- Pozostałe informacje: Dynamiczne środowisko z doskonałymi możliwościami rozwoju kariery.
- Dlaczego ta praca: Pracuj nad innowacyjnymi projektami, które mają realny wpływ na życie ludzi.
- Kwalifikacje: PhD lub PharmD oraz 5-letnie doświadczenie w dokumentacji regulacyjnej.
Challenging. Meaningful. Life-changing. To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
Responsibilities
- Authors complex clinical documents (eg, Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, 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 worldwide regulatory requirements
- Use document development tools that incorporate artificial intelligence, structured content, programming features, and other evolving approaches to enhance efficiency, quality, and speed of processes.
- 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.
- Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells.
- Comply with internal and external 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 and edit documents as required.
- Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.
- Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.
Qualifications
- PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree
- 5 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
- Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
- Demonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines.
- Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
- Working knowledge of a document management system and basic knowledge of the document publishing process.
To apply, please visit our careers page.
Senior Manager, Global Scientific and Regulatory Documentation – Warsaw – pracodawca: Bristol Myers Squibb
Bristol Myers Squibb to doskonały pracodawca, który oferuje wyjątkowe możliwości rozwoju zawodowego w dynamicznym środowisku. Pracując w Warszawie, będziesz częścią globalnego zespołu, który ceni współpracę i innowacyjność, a także zapewnia wsparcie w zakresie mentorstwa oraz elastyczne podejście do pracy. Nasza kultura opiera się na misji, która inspiruje do działania i umożliwia wpływanie na polityki oraz przyspieszanie aktywacji miejsc badań klinicznych.
Naszym zdaniem te umiejętności pozwolą ci błyszczeć jako Senior Manager, Global Scientific and Regulatory Documentation – Warsaw
Communication Skills
Problem-Solving Skills
Organizational Skills
Compassion
Flexibility
Adaptability
Teamwork
