- Merck & Co. (Rahway, NJ)
- …Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). Responsible for project management of the ... Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (eg Protocol Amendments, ... research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with cross functional areas including: Commercial, Safety, Medical, Clinical Operations , and Legal. This structured approach will allow for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and factoring regional needs, laws, and requirements.- Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business stakeholders ... development, implementation, and maintenance of software systems that support business operations and objectives, with a special emphasis on HCP engagement systems.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are ... in database and research tools.ResponsibilitiesSupport the Head Global QA strategy and operations (RDPVMA QA)on projects needing to be coordinated with both DSI QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the ... in collaboration with relevant stakeholders including Data Management, Clinical Operations and QCP/CDx/Clinical BiomarkersSupport clinical study teams and functional… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... to maximize your potential with us? The Position Responsible for managing day-to-day operations of pharmacy programs. This person will be responsible for driving new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA, as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a ... approval, distribution and lifecycle management of promotional marketing materials. The Manager will oversee the process across designated portions of the portfolio… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions, including market trends, competitive dynamics, patient needs, and regulatory requirements. Stay abreast of industry developments, emerging technologies, ... demonstrated history in portfolio management, indication sequencing, or business operations or related roles Strong understanding of pharmaceutical product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments,… more
- Fresenius Medical Care (Bronx, NY)
- …clinical operations in accordance with all legal, compliance, and regulatory requirements and programs. Adheres to all requirements of the FMCNA Compliance ... service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements. Ensure provision of quality patient care… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... of brand plansStrong communication and presentation skillsUnderstanding of legal and regulatory issues impacting pharmaceutical product marketing as well as the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brand attorney and the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products and to specific ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Tris Pharma (Monmouth Junction, NJ)
- …between marketing and other cross-functional teams (ie, Medical Affairs, Sales, Regulatory Affairs, Operations , etc.)Collaborates closely with Analytics team to ... and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence… more
