- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, ... and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project… more
- Merck & Co. (Rahway, NJ)
- …region and specific area and discuss this with the respective Global process Team member or Regional Commercial IT leads/members. Collaborate with other Global ... Job DescriptionOur IT team operates as a business partner proposing ideas...more productive and enable innovation. Join our innovative IT team at our company, where we leverage technology to… more
- Merck & Co. (Rahway, NJ)
- …project teams as assigned.MAJOR ACTIVITIES AND RESPONSIBILITIESWork Independently and as a Team member with Integrity - Precision - Accomplishment - Motivational ... Practice (GLP) studies.The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study.The Associate Principal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This individual is a member of the Development and Medical Affairs QA leadership team and maybe extended member of the global RD/PV QA leadership team . ... strategic initiatives in close collaboration with cross functional leadership team (ie, OBU, SBU) and study teams to uphold...REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are… more
- Eisai, Inc (Nutley, NJ)
- …specific documents and all other documents as requested by Clinical OperationsMaintains sponsor team member staff assignment list for Eisai systems eg. eTMF, ... Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of clinical study and processes… more
- Formation Bio (New York, NY)
- …an emphasis on clinical development related documents within the Research & Development department. This team member will be the first member of a growing ... behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same...at the company shares these same values, and every team and individual plays a key part in our… more
- Merck & Co. (New York, NY)
- …or MD - Required Experience - Knowledge - Skills Work independently and as a Team member with Integrity - Precision - Accomplishment - Principled Ambition - ... Job DescriptionOur Medical Affairs team advances patient care by engaging in scientific...serves as a role model for other field medical team members in ways that include on-boarding and/or sharing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and integrity.This position reports to the Head, Global QMS (RD PV QA) and is a member of the leadership team .Lead an enterprise cross-functional QA team to ... and drives process improvements. Collaborating with the Global QMS eCompliance team , the director oversees QA plans, promotes data governance, and engages… more
- Merck & Co. (Rahway, NJ)
- …key initiatives and priorities for broader Enterprise and TMC&F services categories.- Act as a member of the team willing to carry out the mission and ensure ... Regional Category Manager (RCM) will work with the global team to lead the development and implementation of a...regional/local TMC&F Operations professionals, and the Global Program Design team in a matrix organization.- In addition, the RCM… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC project representative to the CMC sub team and the RA team and serves as ad hoc member to the Global Project Team for late stage projects. This ... preparation of the briefing book, to training and preparing the technical team , to authoring and finalizing the meeting minutes. This position develops awareness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of strategic priorities, resources allocation and capability elevation. As an integral member of the Leadership team , the position will closely collaborate ... and management of the newly created TA Oncology Leadership team and in driving strategy, management and facilitation of...tactical initiatives under the guidance of the TA Leadership team and in partnership with members of the RD… more
- Formation Bio (New York, NY)
- …are looking for a detail-oriented and proactive Staff Accountant to join our growing team . You'll be an integral member of a lean but high-performing Accounting ... behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same...at the company shares these same values, and every team and individual plays a key part in our… more
- Merck & Co. (Rahway, NJ)
- …manage, and continuously improve supplier performance as part of a cross-functional team .Category Team Membership - to be an active member of a category ... for internal review, approval, and signature in collaboration with the CDSP team ; ensure contracts are filed to the appropriate systems and tracked… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …during CDx Indication Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner ... (PoC) for gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea etc.)For recruitment in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …agenda and assist in management of monthly meetings. Maintain Outlook GPM&L member lists. Coordinate and attend GPM&L team building activities.Directly support ... more efficient ways of working within GPM&L or on a project team , enhanced collaboration tools, etc.Schedule and implement on-site/off-site & virtual meetings, (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions, offering guidance and ... support to each product safety team in critical areas such as individual case medical...strategy and harmonize processes that support the department's objectives.ResponsibilitiesA member of DSI CSPV and Global Medical Safety leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. Responsibilities ... quick turnaround, support ad-hoc and exploratory analysis requested by clinical team , provide programming supports in agency response or potential Advisory Committee… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur market access team is passionate about bringing our medicines and vaccines to our customers around the world. We strive to understand our ... to the following responsibilities:Lead the cross functional Global access, Team .Actively collaborate with the global functions including Oncology Global Market… more
- Merck & Co. (Rahway, NJ)
- …organization as a member of the extended GCTO Senior - Leadership Team . Effectively manage resources to ensure appropriately skilled and high - performing staff ... the goals and objectives of the GCTO Senior Leadership - Team (SLT) or extended Leadership Team (eLT). Speak with "one voice" on agreed strategies. - Manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a Global Director of Platform Innovation as part of the Technical Operations team based in Raritan, NJ. Role OverviewLegend Biotech is seeking a Global Director ... processes and outcomes.The Director will build and lead a high-performing small team of technical experts, fostering a culture of scientific curiosity, execution… more
