- 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
- 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
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- Responsibilities: US Agent for all products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for ... new ANDA, NDA, IND and DMF for the US FDA in eCTD format. Preparation, Review and filing of...stages to be compliant with Inactive Ingredient Database and FDA guideline. Review and submit Controlled Correspondences related to… more
- State of Colorado (Denver, CO)
- …plans of correction and recommend certification level or revocation to the FDA through the certification program manager using standard reporting protocols. ... laboratories and other milk testing laboratories under the Food and Drug Administration ( FDA ) Grade A Pasteurized Milk Ordinance of 1995, and law enforcement and… more
- Medtronic (Billerica, MA)
- …IT operations at Danvers and Billerica sites in Massachusetts. The IT Manager will drive operational excellence, optimize business performance, and maximize the use ... as the single point of contact for multi-site and plant leaders, the IT Manager will help unlock business value through IT capabilities and assets. The role also… more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …areas centered around rare diseases and immune disorders. Summary: The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, ... Director, oversee the promotion of the assigned products consistent with the FDA label to assigned customers, using approved messages and resources. *Build, lead,… more
- Michael Page (Skokie, IL)
- …Oversight: Ensure all products comply with applicable regulations and standards, including FDA (21 CFR), FSMA, DSHEA, GMP, FTC, Health Canada, EFSA, and other ... or RAC certification is a plus). Additional certifications or training in FDA regulations, GMP, HACCP, or international regulatory standards (eg, ISO, NSF, FSSC)… more
- Serenity Healthcare (Atlanta, GA)
- Customer Service Manager Serenity Healthcare is a rapidly growing organization looking for our next generation of leaders. If you have an interest in starting a ... this is your opportunity, no healthcare experience required. The Customer Service Manager will work in clinic to educate customers on treatment options and… more
- Custom Goods (Carson, CA)
- Summary/Objective: In this role, the General Manager is responsible for the operation and financial performance by providing direction and leadership to exempt and ... kitting and sales environment preferred. Working knowledge of OSHA, DOT, HAZMAT, FDA regulations Prior experience with the preparation of operating budgets, capital… more
