- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Aequor (Thousand Oaks, CA)
- …Facing SKU Change Records (CFSCR) Provide timely updates to stakeholders, eg, Regulatory , Supply Chain, Manufacturing, Quality on status of GDCR and/or CFSCR ... readiness activities and related projects Represent the SCPM Hub in Project Planning meetings, Variation Execution Meetings and/or Regional Operations Team meetings Establish effective relationships with key stakeholders across multiple functional areas… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HAs, ECs, DMCs, and Academia. L ine management responsibility of Director/ Associate Director Global Safety Lead, Senior Global Safety Scientist(s)/Global ... Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work in a growing ... Clinical Operations Department that manages multiple early-late stage clinical programs. The Senior CPM will be responsible for all aspects of clinical trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director, I&A, the Associate Director, Global Oncology Forecasting will ... DS. The Associate Director serves as a strategic partner to senior leadership by assessing and presenting financial scenarios within the Oncology business unit… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director. Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include leading ... members, Global commercial and New Product Planning teams, Medical Affairs, Regulatory Affairs, Legal, and Market Access. Collaborates closely with Enterprise… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director or Executive Director Safety Surveillance, US East Coast Development ... Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work ... in order to accomplish objectives. Relationships Reports to the Senior Director/Director Program Management Lead. Key internal relationships include brand… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director, GMP QA Process Excellence is accountable to collect information, ... the analysis and redesign of business processes. Ensure compliance with regulatory standards (eg, ICH, FDA, or other industry-specific requirements). Conduct regular… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...internal stakeholders. In the execution of specific projects, the Associate Director, will be accountable for managing relationships with… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director, Digital Strategy - Medical/Access/PSS & Paid Media will serve as ... commercial media efforts in the US. This critical role reports directly to the Senior Director of Digital Strategy and will be expected to work across assigned… more
- Merck & Co. (Rahway, NJ)
- …company's innovations and improve patient health outcomes. Under the guidance of a senior leader, this individual will support the V&I, Outcomes Research teams in ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and ... submissions and NDAs Regular updates with key cross-functional partners (Discovery/Late-Stage/ Regulatory ), as well as other disciplines Establish novel endpoints for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues, ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Merck & Co. (Rahway, NJ)
- …of Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
