- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... accountability. Cross-Functional Collaboration & External Partnerships Partner closely with analytical development, manufacturing, quality, and regulatory teams… more
- Repligen (Waltham, MA)
- …global public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... in accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual filings (eg,… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, and ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …IT, Ethics and Compliance, Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues. Externally, this role ... IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations Physical Requirements 10-20% overnight… more
- Merck & Co. (Rahway, NJ)
- …methodology, we collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Company's Research & ... New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the...scientific role tasked with working closely with the group Director to define group strategy and to lead a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …business execution effectiveness and efficiency across the enterprise. Aside from delivering analytical insights, they will also collaborate with the rest of the AI ... but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation,… more
- Formation Bio (New York, NY)
- …compliance in vendor agreements. Ability to work cross-functionally and influence senior stakeholders. Excellent analytical , financial, and strategic thinking ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure consistency with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing ... 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
- Merck & Co. (North Wales, PA)
- …data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted line ... 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… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Manager, Patient Support Data Intelligence is responsible for process improvement, technology, ... operational execution. Relationships This position reports to the Sr Director , Patient and Consumer Insights. Other key relationships include interactions… more
- SBA Communications Corporation (Boca Raton, FL)
- …Opportunity - Senior Corporate Tax Strategy We are seeking an experienced and Senior Director , Corporate Tax Strategy to lead our global tax strategy for a ... skills. Ability to work collaboratively with cross-functional teams and senior management. Strong analytical and problem-solving skills. Proficiency… more
- MSD (Rockville, MD)
- …Manufacturing and Controls) for pharmaceutical drugs and agents as well as the analytical work associated with that CMC across all of the small molecule projects ... potential drug products, as well as directing the associated analytical work. This position will also be responsible for...also be responsible for the CMC sections of relevant regulatory (FDA and other) documents from INDs to NDAs.… more
- BioSpace (San Francisco, CA)
- …with a new script to outmatch disease. Responsibilities and Duties: The Senior Manager/Associate Director of Clinical Quality Assurance Auditor is responsible ... and ensuring clinical studies are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established quality standards and… more
- Orbital Therapeutics (Cambridge, MA)
- JOB SUMMARY The Senior Manager/Associate Director , Quality Assurance will be responsible for supporting the establishment and maintenance of a comprehensive ... quality management strategy to ensure compliance with regulatory requirements, including those set forth by the FDA and other relevant authorities. This role… more
