- Daiichi Sankyo, Inc. (Bernards, NJ)
- …In Biotech or Pharmaceutical industry10 or More Years Demonstrated success as a project manager /leader in planning and executing strategies for global drug ... proposals and stage gate proposals for formal presentation to senior management. Can step in, as needed, on behalf...strategy committees and have an in depth understanding of project strategies/plans.As a staff manager , responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Senior Manager of Medical Information Operations Excellence supports development, maintenance and ... implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new...improvement and efficiencies for the Medical Information team. The Senior Manager will also serve as the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A Bachelor 's degree from an accredited institution required, additional education /certification within the compliance and healthcare related fields is preferred A ... lifecycle and compliance requirements of post-acquisition timelines Ability to project manage multiple projects to completion meeting internal and external… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval ... and other applicable worldwide regulations and our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our… more
- Aequor (West Chester, PA)
- …and Analysis: o Prepare and present high-quality, data-driven reports for senior leadership and stakeholders, detailing project status, team performance, ... o Provide strategic recommendations based on data analysis to support project management and future initiatives. Qualifications: Education : oA Bachelor's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or related role in a biotech or pharmaceutical company.Demonstrated success as a project manager /leader in planning and executing strategies for global drug ... diseases and immune disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams… more
- Novo Nordisk Inc. (Durham, NC)
- …following activities: People Focus, Equipment Focus & Standards "Gatekeeper". Relationships Manager , Technical Support - OFP Essential Functions Work primarily with ... tools within the main areas of Systematic Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that focuses on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis, strategic planning, internal reporting, and ad hoc reporting and analysis.Responsibilities: Project Planning and Forecasting - Manage and is accountable for ... the development of Clinical Project Budget templates in support of early phase to...multi-functional consolidation process and preparation of financial packages to senior management and to external party for the collaboration… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(including encore abstracts, reviews, and supplements) in collaboration with Publications Manager Independent Medical Education (IME) Assist in developing ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Merck & Co. (Durham, NC)
- …laboratories.The Senior Quality Assurance Specialist will support this expansion. Project activities requiring support include the capital project to ... Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct...objectives. Consults on an as-needed basis with next level manager on more complex decisions. Position Qualifications: Education… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HQ Gain endorsement of US input to PDPs from NNI PDP Forum Partner with Project Manager to track workstreams under the Project Teams Provide cross-functional ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Merck & Co. (Durham, NC)
- …comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.The Quality Senior Specialist provides expertise in the coordination of ... qualification/validation activities supporting the vaccine expansion facility.Primary Responsibilities:The Quality Senior Specialist will be responsible for comprehensive management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for developing and continually growing strong relationships with DS internal senior stakeholders to assess, develop, implement and drive execution of Strategic ... procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to design optimal processes and sourcing solutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management.Responsibilities- Acts as a brand attorney and lead legal advisor ... Division of the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training programs and materials… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... companion diagnostic, academic research organization, and acquisition deals. Advises senior management on legal and regulatory issues, leads complex transactions,… more
- Fidelity Investments (Boston, MA)
- Job Description: Senior Manager - Global Financial Controls Center of ExcellenceThe Global Financial Controls Center of Excellence (GFC-CoE) is an enterprise-wide ... also provides advisory services for select strategic initiatives and modernization efforts.The Senior Manager role will deliver significant value to the business… more
- Fidelity Investments (Boston, MA)
- …us with the deep expertise necessary to build the future of finance. As a Senior Manager - Product Delivery Analysis on the FDA Product Delivery team you ... people. In our agile structure, you will function both independently and as a manager of Business Analysts. Your contributions will enable your team to develop in… more
- HEPCO, Inc. (Manassas, VA)
- For our client, we are seeking a highly skilled Project Manager to lead and manage strategic projects that align with business goals. The ideal candidate will ... (KPIs) to monitor project progress and success. Prepare detailed project status reports for senior management, highlighting achievements, challenges, and… more