- Teleflex (Morrisville, NC)
- …for planning, coordinating, and delivering clinical projects within the Clinical Medical Affairs (CMA) organization. The CPM3 will manage projects such as oversight ... on time, within scope, and budget. The CPM3 will report to the Director , Clinical Programs & CMA Enterprise Excellence and work closely with cross-functional teams,… more
- Sumitomo Pharma (Raleigh, NC)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sumitomo Pharma (Raleigh, NC)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Fujifilm (Research Triangle Park, NC)
- **Position Overview** The Director , Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies ... procedures, offering strategic direction throughout the organization. Additionally, the Director leads a team of regulatory specialists...+ Leads, mentors, and sets the objectives for the Regulatory Affairs team across the North Carolina… more
- United Therapeutics (Raleigh, NC)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Merck (Raleigh, NC)
- **Job Description** + The Precision Medicine - Medical Affairs Director - Health Systems Oncology (PM MAD-HSO) develops ongoing professional relationships with ... account plans in partnership with Precision Medicine Health Systems Oncology Medical Affairs Director (PM HSO-MADs), oncology account management, and precision… more
- WelbeHealth (Raleigh, NC)
- …stakeholders. **Essential Job Duties:** + Lead the WelbeHealth federal legislative and regulatory affairs function with Congress and the Centers for Medicare ... providing an all-inclusive care option to our most vulnerable senior population. The Director , Federal Government Affairs will lead a bold advocacy strategy to… more
- Wolters Kluwer (Cary, NC)
- …nurses, accountants, lawyers, and tax, finance, audit, risk, compliance, and regulatory sectors. We help professionals deliver deep impact when it matters ... strategic message to our key internal and external stakeholders, is seeking a Director , Executive Communications, to support the health division, based in the US… more
- Veterans Affairs, Veterans Health Administration (Durham, NC)
- …related to MR Safety. f. MRSO maintains all aspects of MRI safety regulatory compliance. g. Responsible for implementing and compliance with regulatory ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Complete all application requirements detailed in… more
- IQVIA (Durham, NC)
- …for the Data Management, Biostatistics, Programming, Medical Writing, Lifecycle Safety, and Regulatory Affairs functions - and will be responsible for achieving ... ** Director , Data Sciences, Safety and Regulatory ,...Management, Biostatistics, Statistical Programming, Medical Writing, Lifecycle Safety or Regulatory Affairs field is beneficial. IQVIA is… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …, legal, and ethical guidelines + Foster strong partnerships with Medical Affairs , Clinical Development, Market Access, Market Research, Regulatory , Legal, and ... our focus to ultra-rare neurological conditions. **Job Summary** The Executive Director , Sales and Marketing, Neurology Rare Disease will be responsible for… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... **Associate Director , Small Molecule Analytical Development** + Lead and...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- United Therapeutics (Research Triangle Park, NC)
- …across multiple functional groups (eg, Research and Development, Manufacturing, Validation, Regulatory Affairs , etc.). Negotiate and manage expectations across ... and mentoring or developing a member of your team. The Associate Director , QA Engineering will provide advanced support and subject matter technical expertise… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Position Summary:** The Director GVE Operations oversee and coordinates projects within the department to ensure alignment with organizational goals. This role is ... other integrated data generation initiatives. This position reports to the Senior Director , Global Integrated Evidence & Innovation Operations and can be based in… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... **Position Overview:** The Senior Director , MSAT Biologics provides strategic and technical leadership...validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process… more
- United Therapeutics (Research Triangle Park, NC)
- …organ diseases for which transplant is not currently an option. The Medical Director - Medical Monitoring will ensure individual subject safety and the scientific ... products in accordance with ICH Good Clinical Practice (GCP), applicable regulatory guidelines and company standard operating procedures (SOPs). Will support… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …data scientists and data programmers, and external stakeholders including Medical Affairs , Value and Real World Evidence to provide end-to-end statistical expertise ... approve tables, listings and graphs specifications. + Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and… more
- Prime Therapeutics (Raleigh, NC)
- …Sr Dir Pharmacy Trade Relations - Remote **Job Description** The Sr Director , Pharmaceutical Trade Relations is responsible for managing Prime's Trade Relations ... on Medicare Part D and Managed Medicaid. The Sr Director , Pharm Trade Relations leads a team of directors...needs in rebate contracting. + Serve as a government affairs expert including providing support to Prime's gov't … more
- Chiesi (Cary, NC)
- …your primary purpose is to serve as the organizational conduit between US Medical Affairs management and our PAH field based medical science liaison (MSL) teams in ... the assigned therapeutic area goals and objectives. + Communicate with medical affairs leadership to ensure alignment, share best practices/ and key learnings across… more
- Lenovo (Morrisville, NC)
- …seeking an experienced professional to manage the company's state and local governmental affairs strategy in the US The successful candidate will work closely with ... some US and international travel. **Responsibilities:** + Work together with the director , Government Relations NA, and the extended team to advance public policy… more
