- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Lundbeck (Waco, TX)
- …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
- Lundbeck (Joliet, IL)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... internal and external customers on GxP related regulations / guidelines (eg, FDA , EU, ICH) and company procedures and policies.International experience including EU… 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)
- …and Good Pharmacovigilance Procedures (GVP) required4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred4 or More Years Familiarity ... with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP), PharmD, RN, or master's degree in life sciences preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA , EMA) (Required)2 or more years with experience working with international… 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 ... to prepare for tomorrowTrack record of successfully leading audits and inspections ( FDA , EMA, etc.)An ability to build strong partnerships and effectively integrate… more
- Macpower Digital Assets Edge (Los Angeles, CA)
- …to evolving consumer needs. About the Role: As the Senior Regulatory Affairs Manager , you will ensure regulatory compliance for cosmetic, OTC, dietary supplement, ... and launch. Maintain adherence to company ingredient policies and applicable regulations ( FDA , Health Canada, EPA, etc.). Review and approve product claims, ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager .Regulatory ... and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating ... and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross...systems are completed in a manner in compliance with FDA , EU and NN regulations Responsible for the verification… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which includes but ... in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining to… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... etc.Remain on the cutting edge of data readouts (consistent with FDA -approved labeling), medical congress meeting outputs and podium & symposia… 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 ... SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation.Strong organizational skills with… 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 ... to understand geometrical dimensioning and tolerancing. *Experience in an FDA regulated or regulated industry beneficial (Medical device preferred) -Experience… 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 ... to deliver quality and on-time Quotations to Clients. The Senior Manager , Client Services, identifies and independently drives delivery of strategic process… more
- Walgreens (Redmond, WA)
- Walgreens Registered Manager Local Specialty 1645072BR Job Description Job Summary Responsible for directing the operation of a Walgreens Local Specialty Pharmacy, ... growing the business at the site. Performs all duties of the Pharmacy Manager in their absence . Customer Experience Ensures that store personnel provide hospitable… 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
- CryoLife (Kennesaw, GA)
- …and government, industry, and company GCP standards. Present GCP, compliance, and FDA BIMO inspection readiness proficiency training on an as needed basis. Support ... systems preferred. Expert knowledge of international GCP regulations is a plus ( FDA , MHRA, PMDA, and ICH). Excellent written and oral communication and presentation… more
