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... the development of the CMC regulatory strategy for submissions. These submissions ... IND/CTA, NDA, CTD and MAA regulatory filings. Collaborate with other relevant ... to prepare and review CMC..
... Description The GRS-CMC organization provides regulatory expertise related to CMC activities ... of the organization develop global regulatory CMC strategies and partners with ... priorities. The team also perform..
... Matter Expert for input to regulatory product labeling and participate/provide input ... provide safety lead support global submission document production and review. Lead ... Topic Reviews) and ad hoc..
... Squibb Company Position: Senior Technical Manager (ref.#1550) Location: 3551 Lawrenceville Road, ... Clinical Safety and Efficacy), and regulatory requirements; expertise in statistical programming ... comprehensive programming expertise to clinical..
... and make a difference. Global Regulatory Manager, Business Operations for Global Regulatory Strategy & Policy Responsibilities Support ... Strategy & Policy Responsibilities Support Regulatory Lead in the preparation of..
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas ..
... are seeking a R&D Engineer Project Manager I for a very important ... work. Primary Responsibilities: - The Project Manager is responsible for providing cross-functional ... is responsible for..
... transformative business results. Summary The Manager of Global Risk Management will ... This includes RMP, REMS FDA submission activities, RM Assessments Reports, and ... colleagues as well as external..
... Combination Product QA, the Sr. Manager, Digital Products QA is responsible ... partners including software developers, testers, project managers, and commercial teams to ... commercial teams to deliver on..
... transformative business results. Responsibilities: Represent regulatory CMCon matrix teams while providing ... strategic guidance related to current regulatory requirements and expectations for marketing ... molecule projects Review and provide..
... Description The GRS-CMC organization provides regulatory expertise related to CMC activities ... of the organization develop global regulatory CMC strategies and partners with ... Summary / Objective The CMC..
... conjunction with GSM regarding when project data standards can and should ... for all studies in a project CRF Completion Guidelines, to ensure ... consistency across studies within a..
... Team Leadership responsibility for global regulatory strategy across multiple development teams ... (DTs). Leadership responsibility for global regulatory strategy across multiple DTs, including ... coaching and mentoring of Global..
... Team Leadership responsibility for global regulatory strategy across multiple development teams ... multiple development teams (DTs). Develop regulatory strategy for Oncology products from ... Responsibilities Leadership responsibility for global..
... Advise and support local Global Regulatory Sciences (GRS) for assessing regulatory landscape and regulations to optimize ... and regulations to optimize our regulatory strategies and submission plans within and..
... Sciences (BDS) Statistical Programming Technical Manager provides functional expertise and leadership ... comprehensive programming expertise to clinical project teams in support of development, ... teams in support of development,..
... Bristol-Myers Squibb Company Position: Technical Manager (Ref: 1523) Location: 3551 Lawrenceville ... trial methodology, statistics and global regulatory requirements such as Clinical Data ... and maximize quality during a..
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and ..
... and transformative business results. Summary Project manager for US Clinical Trial Management ... according to SOPs, GCP and regulatory guidelines. Coordinates and maintains effective ... industry and the pre-clinical,..
... assume leadership responsibility for global regulatory strategy within a development team ... or co-lead of marketing application submission teams for indications that are ... indications that are at the..
