- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi...affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA , EMA) (Required)2 or more years with experience working… more
- Lundbeck (Edmond, OK)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …selected candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with ... role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing...and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross… more
- Lundbeck (Raleigh, NC)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership in developing PV goals, continued compliance, and strategy for process improvement initiatives. Qualifications: Successful candidates will be able to meet ... and Good Pharmacovigilance Procedures (GVP) required4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred4 or More Years Familiarity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing, MFG support operations, Mock ... cell, and CAR-T process ) according to standard operating procedures and batch records...and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel,… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... user access management, training, programming support & upgrades Manage automated process for converting clinical data to standard normalized datasets which are… more
- IntePros (Mahwah, NJ)
- Project Manager , Engineer - Onsite- NJ Our client, one of the leading medical device companies in the world is seeking a senior PM to support two new product ... launches. Job Duties -Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance… more
- Catalent, Inc. (Philadelphia, PA)
- Sr. Client Services Manager Position Summary: Line management of a team of Proposal Leads to deliver global opportunities. As a key member of the client relationship ... role is responsible for strategic oversight and leadership of the proposal process , including guiding cross-functional teams to scope opportunities and gain key… more
- BioSpace (Tarrytown, NY)
- Job Details The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with ... from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s)… more
- SkyElia (Paramus, NJ)
- About the job Project Manager , Medical Devices The Project Lead is responsible for providing cross-functional program leadership to ensure projects achieve desired ... detailed management status reports. Ensure projects are run in compliance with company, FDA , and ISO procedures. Oversee and provide guidance across all phases of… more
- Revolution Medicines (Redwood City, CA)
- …with RevMed SOPs, and global regulatory requirements. Establish a risk-based process /framework to plan, conduct audits, qualifications, and oversight based on ... Minimum of 5+ years' experience supporting regulatory inspections (eg, FDA , EMA, PMDA) in support of BIMO/PAI including conducting...us by email or phone. We will only collect, process and use any personal data that you provide… more
- dsm-firmenich (Exton, PA)
- Manufacturing Engineering Manager Exton, PA (On-Site) The Manufacturing Engineering Manager will provide purpose, direction, and motivation while operating to ... will direct or participate on project teams within the PMP/project management process . This position manages product lifecycle support for running business. This… more
- Real Chemistry (New York, NY)
- …should be. But we can't do it alone - you in? Real Chemistry is looking for a Manager or Senior Manager , Social Media to join our growing team! This role is part ... platforms, tools, and trends-both personally and professionally Strong understanding of FDA and FTC regulations governing social media within regulated industries… more
- Biotronik (Lake Oswego, OR)
- Territory Manager , Neuro - Detroit, Michigan At BIOTRONIK Neuro, we're ready to redefine relief for patients experiencing chronic pain. Leveraging BIOTRONIK's ... needs of patients and providers. BIOTRONIK Neuro is looking to add a Territory Manager to our Neuromodulation Segment in Detroit, Michigan. As Territory Manager … more
- Coregistics (Acworth, GA)
- Quality Manager Position Summary: The Quality and Operations Manager will be responsible for overseeing and managing the quality control and food safety systems ... external standards, and driving continuous improvement across the production process . Responsibilities: Develop, implement, and maintain comprehensive quality assurance… more
- Volastra Therapeutics (New York, NY)
- …the clinic in Q2 2024. Both assets have been granted Fast-Track Designation by the FDA . Volastra is backed by top US and European venture firms such as Arch, ... visit www.volastratx.com for more information. JOB DESCRIPTION The Development Project Manager , Oncology (Senior Manager /Associate Director) will report to the… more
- Yokogawa Electric Corporation (Sugar Land, TX)
- …are highly valued and exhibited in everything we do. The Quality Assurance (QA) Manager is responsible for leading and elevating our quality programs across a lean, ... with the parent company headquartered in Japan. The QA Manager supports the Corporate QHSE Manager in...follow-up activities. Ensure compliance with applicable regulatory requirements (eg, FDA , CSA, UL, ATEX, IECEx, ANSI, OSHA, etc.) across… more
