- Merck & Co. (Rahway, NJ)
- …Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, ... Job DescriptionAssociate Director , Business System Labeling Management Required experience and...and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and ... risk management activities.Lead the preparation of materials for program presentations for management review and regulatory submission.Contribute to the… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. -...areas, including: - Responsible for achieving results on major program drivers by implementation of one or more novel… more
- Insmed Incorporated (San Diego, CA)
- …transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the ... Unit (internal or external QC). May act as a program lead on a PDT as required by the...as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take… more
- Merck & Co. (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Eisai, Inc (Nutley, NJ)
- …milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level oversight of Clinical development plans (CDP) ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...(or equivalent role) with Global Clinical Lead or Clinical Program Director accountability. Proven experience in running… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... vaccines.Helps achieve / sustain reimbursement and market access for the program and indications under their responsibility.Critically assesses drivers and barriers… more
- Merck & Co. (North Wales, PA)
- …operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance). Responsible for ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping… more
- Eisai, Inc (Exton, PA)
- …Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains ... close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Relationships This position reports into a Vice President or Sr. Director within the National Account Market Access Teams. Internally, this position has ... Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of… more
- Novo Nordisk Inc. (WA)
- …potential? This role can sit in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex issues that will require an in-depth ... globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted line with Corporate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, ... disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ; and voluntary benefits such as… 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, ... listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual… more
