- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reviews and authoring reports and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected ... to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of study… more
- Eisai, Inc (Exton, PA)
- …to improve efficiency. Essential Functions 1. Development Projects Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and ... Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout… more
- Eisai, Inc (NJ)
- …a contract research organization or other relevant providers. Knowledge of clinical research process and regulatory environment Demonstrates business/financial ... Suite#LI-TS1Eisai Salary Transparency Language:The base salary range for the Manager , Clinical Outsourcing is from :102,100-134,000Under current guidelines,… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted ... flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. Support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of the ... end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near real-time… more
- Aequor (Thousand Oaks, CA)
- …to optimize the demand/supply planning and inventory management in support of regulatory filing, clinical /commercial supply, and/or product launch and lifecycle ... top of the resume is seeking a Supply Chain Manager to be a part of our External Planning...objective is to orchestrate supply planning and delivery of pre- clinical , clinical , PPQ and commercial inventory of… more
- Lundbeck (Minneapolis, MN)
- …and transform lives. Join us on our journey of growth! As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our CNS ... Skilled Nursing Facilities.You will drive demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strong understanding of pharmaceutical product development processes, including clinical development, regulatory pathways, and commercialization strategies, ... decisions, including market trends, competitive dynamics, patient needs, and regulatory requirements. Stay abreast of industry developments, emerging technologies,… more
- Lundbeck (Stamford, CT)
- …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 ... strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and develops ... HEOR, Future Business Strategy, Commercial, Account Management, Analytics, Legal, Regulatory , Investor Relations, Value Communication and Contracting Strategy colleagues,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term ... market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs, Government Affairs… 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
