- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a ... be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey.... representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Category Leaders and Managers Scopes out high-profile supplier engagements for senior level executives, develops and negotiates agreements and manages suppliers to ... under adversity Operational mindset and continuous improvement: Considers compliance, regulatory , quality assurance and other requirements when supporting all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will ... marketing execution and budget management.Ensure planning and readiness for senior business and strategy reviews and stakeholder engagement.Engagement with… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Associate Director , Medical Operations, Innovation and Emerging Projects (AD, IEP) is a role within Global Medical and Value ... in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director , Medical Operations, Innovation and Emerging Projects Lead.The AD, IEP is an… more
- Novo Nordisk Inc. (Boulder, CO)
- …small molecules and oligonucleotide products. Relationships This position reports to Senior Director , Chemical Development. Essential Functions Lead the ... and evaluate problems and determine appropriate solutions utilizing an array of analytical techniques Support regulatory filings as necessary Support the overall… more
- Merck & Co. (Rahway, NJ)
- …and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... our company's 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
- Novo Nordisk Inc. (Boulder, CO)
- …raw materials and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions ... Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory ,… 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 ... to other clinical scientists.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues, ... Years Extensive experience in project management, process, product, and/or analytical development activities and pharmaceutical/oncology project development preferred- 1… more
- Novo Nordisk Inc. (Boulder, CO)
- …Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , ... are driving change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a seamless user experience for customers. Relationships Reports to the Associate Director of Content Management; Provides direct support to the Digital Marketing ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr ... Director , Analytical Regulatory Science, is responsible for supervising...communication skills (written and verbal) including experience presenting to senior leaders. + Ability to influence cross-functionally to integrate… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and help… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **TITLE:** ** Senior Director , Commercial Analytical Operations - Biologics Quality ... Control (Grade 33)** **KEY RESPONSIBILITIES:** The Senior Director Commercial Analytical Operations...to the QC team for timely project completion and regulatory compliance. **FOCUS AREAS** You Will: + Oversee the… more
- Huron Consulting Group (Chicago, IL)
- …Cycle Operations and critical factors to ongoing Revenue Cycle success. The HIM System Regulatory Sr Director leads HIM functions in complex mix of high-volume, ... for this person to work with the site HIM director to assure compliance. + This role will involve...experience, with at least 7 years progressive leadership or senior management role + Comprehensive understanding of regulatory… more
- BeiGene (San Mateo, CA)
- **Position Summary:** The Senior Director is responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence function. ... BeiGene's corporate vision, mission, and values. As the Head of Global Regulatory Operations, the SD will lead key functions (Submission Operations Management (SOM),… more
- Google (San Francisco, CA)
- …ensure constructive engagement with governments and regulators while mitigating risk. As Senior Director , Regulatory Affairs, Content Advisory Global Lead, ... + 15 years of experience in legal, compliance, and regulatory risk. + Admitted to the bar and in...issues. + Excellent written and verbal communication, time management, analytical , investigative skills, attention to detail with the ability… more
- Gilead Sciences, Inc. (Frederick, MD)
- …, to lead Quality Control Analytical Tech Services group, reporting to the Senior Director , Quality Control in Frederick, MD. In this role, you will lead ... a group and work closely with the Senior Director and other Associate Directors on...cell-based bioassays** and lead **efforts in automation development for analytical assays** . You will have cross-functional interaction with… more
