- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... are in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains proficient understanding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... internal and external customers on GxP related regulations / guidelines (eg, FDA , EU, ICH) and company procedures and policies. Competencies:Professional or other… more
- Lundbeck (Fresno, CA)
- …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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... understanding of local/federal laws and applicable regulations applicable (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards (ie. Good… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and… 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
- 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
- Repligen (Waltham, MA)
- …based in Waltham, MA, and will report to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and ... systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP, etc.). Excellent communication, negotiation, and interpersonal skills. Willingness… 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
- Cytiva (Pensacola, FL)
- …about the Danaher Business System, which makes everything possible.As the Senior Manager , Site Quality you will collaborate closely with cross functional leadership ... Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA or EPA-regulated manufacturing environments.Possess a minimum of 4 years of… more
- Leica Biosystems (Miami, FL)
- …Use Only (RUO) product development and sustainment.This position reports to the Senior Manager , Regulatory Affairs and is part of the Global Regulatory Affairs Team ... the opportunity to:Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and Technical File… more
