- Genmab (NJ)
- …readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight ... 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 within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director , Utilities Electrical Engineer is a member of the Plant Engineering team providing technical support to the Durham Site.- ... procedures, engineering design guidelines and business plan; receives guidance from manager when necessary.Provides & Implements technical guidance to given tasks,… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Durham, NC)
- …Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… more
- Genmab (NJ)
- …and tactical operational plans aligned to the commercial and regulatory objectives.Excellent stakeholder management, concise written communication, ability to ... of the external environment may impact their area of responsibility. People manager : Lead a small/ local team to ensure oversight of deliverables, development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… 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 ... the design and construction of the facility, the Operations Manager will play a critical role in supporting the...and any action plans to address gaps to the Associate Director and/or Director -… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Maintenance Specialist P2 DaysPrimary ResponsibilitiesReporting to the Associate Director of Maintenance and Engineering or the shift ... Maintenance Manager , the Maintenance Specialist primary responsibility will be to...inclusion, feedback and empowerment.Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.Ability… more
- Boehringer Ingelheim (Athens, GA)
- …such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or ... **Description** Manager The Manager , Regulatory ...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- Abbott (Alameda, CA)
- …location in the Diabetes Division. As a manager , the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge ... work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work… more
- AbbVie (San Francisco, CA)
- …multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director , or Director ), in ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & Canada position is responsible for the… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development ... + Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Interactions:** Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- CUNY (Bronx, NY)
- Associate Director of Compliance and Operations (Financial Aid Manager ) **POSITION DETAILS** The City University of New York (CUNY), the nation's largest ... urban university system, is seeking a passionate and dedicated Associate Director to join the Financial Aid...related duties as assigned. Job Title Name: Financial Aid Manager **CUNY TITLE** Higher Education Associate **FLSA**… more
- University of Washington (Seattle, WA)
- …by ensuring credentialing practices meet the highest standards of safety, legality, and regulatory integrity. The Associate Director ensures alignment with ... risk mitigation, regulatory interpretation, and performance improvement, the Associate Director leads credentialing compliance across multiple entities. This… more
- Sumitomo Pharma (Phoenix, AZ)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The AD. CRA Manager provides/supports resourcing strategy and personnel oversight within the Site Management organization The AD. CRA ... Manager develops/supports metrics and KPIs for CRA staff addressing...performance and results of multiple related teams Supports SR Director to develops departmental plans, including business, production and/or… more
- ThermoFisher Scientific (Cambridge, MA)
- …Delivery is vital to helping our customers deliver life-changing therapies. **Position:** Associate Director /Senior Project Manager , Drug Development, FSP ... **Environmental Conditions** Office **Job Description** **AD Project Management/Senior Project Manager (Delivery)** At Thermo Fisher Scientific, you'll discover meaningful… more
