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Bristol Myers Squibb
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Cambridge, Massachusetts
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patients and health care providers we serve.
The Manager, Program Management; Translational Sciences ... translational and diagnostic strategies, projects, and lifecycle plans.
In the role as a (Manager) within
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Bristol Myers Squibb
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Devens, Massachusetts
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/working-with-us .
The Manager, Chief Boiler Engineer will provide people leadership to the facility ... , manuals, presentations and articles using distinctive style.
Regulatory experience and safety
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Bristol Myers Squibb
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Devens, Massachusetts
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infrastructure upgrade projects, develop Quality Review Manager (QRM), labels, and reports, and provide training ... troubleshooting.
Execute Quality Review Manager (QRM), labels, and reports development projects within the
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Bristol Myers Squibb
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Devens, Massachusetts
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preparation of CMC documentation for regulatory filings and responses for the BMS Devens commercial ... process subject matter expertise for regulatory inspections and other interactions with regulatory
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Bristol Myers Squibb
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Cambridge, Massachusetts
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leadership)
Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with ...
Provision of information required by Protocol Manager for development of trial budget, CRO scope of work
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Bristol Myers Squibb
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Cambridge, Massachusetts
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and relevant science in order to meet regulatory and disease strategy targets
Provides oversight ... literature
Keeps abreast of development and regulatory issues related to other competitive or relevant
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Bristol Myers Squibb
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Devens, Massachusetts
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Manager of EOHSS for the Devens Facility. As the Manager this person will play an active role in ... accordance with company and regulatory requirements. This position plays a key role in aligning corporate and
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Bristol Myers Squibb
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Devens, Massachusetts
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/working-with-us .
Reporting to the Associate Director, Senior Manager of the Single Use Facility is ... utilizing single-use technology.
The Senior Manager leads and drives the execution of commercial and
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Bristol Myers Squibb
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Devens, Massachusetts
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defend their work before regulatory agencies.
Duties may include internal compliance or efficiency ... regulatory environment (FDA, EU).
Proficiency in project management, oral communication, and technical
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Bristol Myers Squibb
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Devens, Massachusetts
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data inquiries from regulatory agencies and matrix teams using data systems (LIMS, Discoverant, Datalake)
Provides data and analysis for regulatory inspections and other interactions with regulatory
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Bristol Myers Squibb
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Cambridge, Massachusetts
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activities for the pipeline and supports late stage portfolio for regulatory, translational development and ... , regulatory interactions and label negotiations
Proven ability to work with global disease teams to
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Bristol Myers Squibb
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Devens, Massachusetts
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manufacturing process changes, optimizations, and regulatory filings. Optimizing the manufacturing process and ... standards and regulatory requirements.
Leverage and maintain strong relationships with external CMOs
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Bristol Myers Squibb
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Cambridge, Massachusetts
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Ensure studies are designed to meet regulatory, quality, medical, and access goals
**Position ... functional author for Regulatory submissions, study reports, and publications
Independently synthesizes
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Bristol Myers Squibb
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Cambridge, Massachusetts
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programs.
Contribute to regulatory filings of biotherapeutics.
Prepare reports, papers, and ... authorship of patents, regulatory documents.
These qualifications and responsibilities will enable the
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Bristol Myers Squibb
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Cambridge, Massachusetts
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activities of multiple projects; be responsible for preparation of regulatory dossier/responses; and assist ... clinical trials and global drug registrations. Interact s with regulatory authorities to address questions
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Bristol Myers Squibb
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Cambridge, Massachusetts
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activities of multiple projects; be responsible for preparation of regulatory dossier/responses; and assist ... clinical trials and global drug registrations. Interact s with regulatory authorities to address questions
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Bristol Myers Squibb
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Devens, Massachusetts
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efforts.
May represent the department in regulatory inspections (internal and external audits
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Bristol Myers Squibb
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Cambridge, Massachusetts
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support development
Serving as principal functional author for Regulatory submission, study reports ... of the literature
Keeps abreast of development and regulatory issues related to other
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Bristol Myers Squibb
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Devens, Massachusetts
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, Commercial, Regulatory and GPS. Serve as a member of the Cell Therapy Development Operations Leadership Team ... regulatory authority communications and ensure that all submissions and communications occur on time and with
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Bristol Myers Squibb
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Cambridge, Massachusetts
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) activities
Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
Qualifications & Experience
Degree in
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Bristol Myers Squibb
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Boston, Massachusetts
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working knowledge of relevant regulatory and compliance issues related to the MVL role
Ability to
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Bristol Myers Squibb
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Cambridge, Massachusetts
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adapting best practices and maintaining rigor in light of emerging regulatory guidelines for mechanistic
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