- Genmab (NJ)
- …and feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role ... is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …QMS capabilities that touch every aspect of our business processes, systems, and data .The Associate Director will collaborate and interact with ... Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of… more
- Eisai, Inc (Exton, PA)
- …difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading ... well as supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing… more
- Merck & Co. (Durham, NC)
- …Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Excellence will guide launch planning and execution at NNI ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...This individual will have a proven track record in product marketing, including product launch experience. This… more
- Merck & Co. (North Wales, PA)
- …individuals who are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the ... Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper...the forefront of transforming the US market through innovative product launches and launch excellence within our US Market… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Operations will play a pivotal role in managing the ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
- Merck & Co. (North Wales, PA)
- …medicines that help people around the globe. We are currently recruiting for Associate Director , US MarketingThe role will oversee foundational strategy and ... strategy development and execution for anticipated launches, identifying both product and franchise opportunitiesPartnering with sales leadership and customer facing… more
- Genmab (NJ)
- …to building extra[not]ordinary(R) futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines(R) that change ... Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other devices to enhance the value of our oncology pharmaceutical products .Responsibilities: CDx development : Provide critical strategic and tactical regulatory ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Merck & Co. (Rahway, NJ)
- … products , as well as combination product stewardship for inline products . The Executive Director will lead multiple functions in the department of ... across technical transfer initiatives, working collaboratively with the Senior Director , Directors, and Associate Directors, and cross-functional teams.Utilize… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... is also accountable to promote a quality culture within across the product portfolio by providing governance support, quality oversight of strategic initiatives in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... 14 weeks Paid Parental Leave Free access to Novo Nordisk-marketed pharmaceutical products At Novo Nordisk, you will find opportunities, resources and mentorship to… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... aspects of Cell Culture process development/commercialization for large molecule products .Responsible for process development, process characterization and regulatory filing… more
- Merck & Co. (Durham, NC)
- …policies, procedures and business plan; receives guidance and oversight from Operations Associate Director and Director ;Interprets client and/or customer ... to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend...and any action plans to address gaps to the Associate Director and/or Director .- Identify,… more
- Merck & Co. (Durham, NC)
- …procedures and business plan - Receives guidance and oversight from Operations Associate Director and DirectorInterprets client and/or customer needs and ... objectives even through adversity. This role will support drug product in regulated, clean room environments complying with current...and any action plans to address gaps to the Associate Director and/or Director -… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... to make a difference? The Position Manage and oversee all assigned projects/ products /processes. Assist the Director in assuring Novo Nordisk compliance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and MAPA teams to provide scenarios in predicting contract change impact. Helps Associate Director , Market Access Insights in creating market access situation ... Senior Manager - Market Access Insights works with the Director - Market Access Insights to explore key market...Market Access Insights & Analytics team in adopting advanced data engineering methods. Continues to assess product … more
- Eisai, Inc (Pittsburgh, PA)
- …Works with office management to provide various informational resources, such as product data , and builds appropriate relationships with key personnel. ... with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and… more
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