Manager, Patient Safety Scientific Writing

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Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: Summary

Leads document strategy and authoring of message-driven clear and concise regulatory documents in support of submissions and approvals in key markets and other geographies. Provides support for fit-for-purpose regulatory documents (clinical pharmacology clinical safety) to facilitate speed of information during development submission approval and life cycle management of products in BMS pipeline.

Objective: 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.

Duties/Responsibilities

• Coordinate and author regulatory documents eg Investigators Brochures (IB) development safety update reports periodic benefit-risk evaluation reports clinical study reports (CSR) Risk Management Plans (RMPs) and protocols ensuring the coordination and integration of the scientific medical and regulatory input from development team members.
• 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.
• 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 timely completion and high quality of assigned documents

Requirements

• Minimum of BS/BA degree in science (PhD/PharmD/Masters degree preferred) with approximately 1-2 years of regulatory documentation or related experience (does not have to be regulatory documentation). All PhD in biological sciences and PharmD candidates are considered.
• Strong writing skills in authoring and managing the production of scientific documents (pharmaceutical regulatory documentation and/or publications in peer-reviewed journals).
• Ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Basic understanding of global pharmaceutical drug development.
• Ability to manage timelines and quality of work using strong organizational communication facilitation and interpersonal skills in a cross-functional team.
• Expertise in MS Office.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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R: Manager Patient Safety Scientific Writing

Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1