- Formation Bio (New York, NY)
- …product release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at ... bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution… more
- Lundbeck (New York, NY)
- …and transform lives. Join us on our journey of growth!BioPharmaceutical Regional Business Director - East Will consider candidates who live in region or state which ... Excluding MN, WI, IL, IN and parts of KY.SUMMARY:The Regional Business Director (RBD) is responsible for leading field-based Area Sales Managers (ASM) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial risks, progress/performance, timelines, and ... relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes knowledge of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position The Scientific Global Medical Director will provide leadership, direction, and guidance for the development and ... This role involves overseeing and driving implementation science, ensuring compliance with regulatory and institutional review boards, and facilitating collaboration… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Staff members of the Medical Promotional Review team report to the Director . Works with stakeholders throughout NNI and at external agencies. Key internal ... other key internal cross-functional teams where (s)he provides strategic input. The Director represents Medical on PRB working group and Steering Committee brand… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing the mission of our organization ... the highest standards of scientific integrity, patient safety, regulatory compliance , and collaboration across therapeutic areas. Ultimately, this position aims… more
- Formation Bio (New York, NY)
- …closeout. This role ensures that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of ... bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and overseeing… more
- Formation Bio (New York, NY)
- …the PositionFormation Bio is seeking a highly skilled and experienced Senior Director , Biostatistics to join our dynamic team. This critical role will report ... and leveraging biostatistics to advance our drug development processes.The Senior Director , Biostatistics will play a key role in shaping innovative trial… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ensuring quality, ... and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA, EMA), industry standards (eg, cGMP),… more
- Genmab (Plainsboro, NJ)
- …managing the key area of field force incentive compensation. The Associate Director of Field Operations - Incentive Compensation works closely with field leadership ... from design and implementation to payouts and leadership updates. The Associate Director of Field Operations - Incentive Compensation will report directly to the… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The Role.The Director , Privacy Technologist & Third-Party Privacy Risk reporting into the Head of ... and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep understanding of data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice ... and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions Provide strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access), Brand Marketing, Training, Market Access & Public Affairs, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to ... in order to accomplish objectives. Relationships Reports to the Executive Director , Patient Support Solutions. Key internal relationships include brand marketing,… more
- Genmab (Plainsboro, NJ)
- …external vendors for all aspects of program execution, tracking & reconciliations, compliance , and reporting. Daily interaction with KOLs, field force & field ... colleagues including field representation, sales operations, BIS, IT, and Compliance to ensure optimal execution. Make strategic recommendations to Sales… more
- Tris Pharma (Monmouth Junction, NJ)
- …from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director , Head ... materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees… more
- Genmab (Plainsboro, NJ)
- …briefings; agency request responses) as applicable, in markets within scope Drive compliance by providing guidance and advice to cross-functional teams on market ... legislation and other regulatory requirements as applicable Liaise and collaborate with internal teams (eg QA, manufacturing), external teams (eg contract manufacturing, CRO, affiliates), and regulatory & health authorities, in relation to matters of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ... on new procedures, to auditing against local and corporate policies, to reporting compliance -related issues, ECP keeps us accountable every step of the way as we… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of modern professionals and learners. Relationships Reports to the Associate Director , Academy and Franchise Employee Experience while collaborating closely with key ... from functions including STARS, Human Resources, and Legal, Ethics & Compliance around learning and development needs. External relationships may include interaction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders including, but not limited to, the Information Technology, Analytics Governance, Compliance , Field Systems and Field Force teams, as well as other NNI ... within other domains (Patient, Product) where applicable.RelationshipsThis role reports to the Director of Data Services & Management within the Enterprise Data &… more
- Genmab (Plainsboro, NJ)
- …a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, Denmark.Main Responsibilities IncludeEngage with ... of clinical drug supply management.Oversee inspection readiness and ensure compliance with relevant regulations.Manage operational trial and project objectives,… more
