- Takeda Pharmaceuticals (Raleigh, NC)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning ... - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global … more
- Takeda Pharmaceuticals (Raleigh, NC)
- …identifying innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory ... Regulatory components of PSMF reporting, adapting strategies based on evolving global regulatory landscape. + Acts as a primary source for business RIM system… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products… more
- Teleflex (Morrisville, NC)
- Associate Global Medical Safety Director (Part Time/Remote US) **Date:** Jan 24, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected ... and medical safety across the global Teleflex portfolio reporting directly to the Global Medical Safety Director . As part of the Clinical and Medical Affairs… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …to the best of my knowledge. **Job Description** **Objectives:** As part of the Global Evidence and Outcomes (GEO) team, this position is focused on documenting the ... decks, statistical analysis plans, briefing packages, clinical study reports, and regulatory labelling interactions. Ensure these reflect the COA needs from key… more
- Merck (Durham, NC)
- …globe. Reporting to the Director of Quality Systems and Compliance, the Associate Director - Quality Systems position will provide leadership, focus and ... review of existing systems and aligned with strategic direction defined by the global business model and regulatory agencies. The role will require working… more
- IQVIA (Durham, NC)
- The Associate Director , Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. ... summary documents. Has a broad understanding of clinical research processes and global regulatory document standards. Mentors less experienced writers. Reports… more
- Lilly (Durham, NC)
- …people who are determined to make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging is responsible for the staffing, ... and Packaging (DAP) production area at Lilly RTP. The Associate Director will help build a strong...10% to Indianapolis, IN for meetings and coordination with global regulatory organizations Lilly is dedicated to… more
- United Therapeutics (Raleigh, NC)
- …for cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key ... oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position strategizes and implements plans to… more
- Lilly (Durham, NC)
- …people who are determined to make life better for people around the world. Associate Director Quality Assurance (QA) Parenteral is responsible for the staffing, ... process including dispensing, equipment preparation, formulation, filling and visual inspection. The Associate Director will help build a strong quality culture… more
- Merck (Raleigh, NC)
- …Pharmacometrics -** **Immune/Oncology** **(QP2-IO)** team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- The Clorox Company (Durham, NC)
- …**Your role at Clorox:** The Associate Director , Head of ... safety guidance to business partners and other internal stakeholders + Address global regulatory toxicology and product safety questions + Manage in-market… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Data Configuration Engineer in our Cambridge, MA office. At Takeda, we ... and transformation templates for reuse for study level configuration tasks. The Associate Director Data Configuration Engineer (DCE) oversees a team that… more
- Lilly (Durham, NC)
- …opportunity to help operate and expand a state-of-the-art manufacturing site. The Associate Director - Maintenance and Reliability Engineering is responsible for ... site expansion including oversight for maintenance related investigations and changes. The Associate Director - Maintenance & Reliability Engineering is also… more
- Lilly (Durham, NC)
- …our company values of Integrity, Excellence, and Respect for People. The Operations Associate Director for Packaging is responsible for the staffing, training, ... up, and validation of the packaging area. The operations associate director will be responsible for overseeing...Environmental/Safety issues. + This role has direct interaction with Regulatory Agencies during site inspections. + Associate … more
- IQVIA (Durham, NC)
- …statistical methods + In-depth knowledge of applicable clinical research regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference ... and organization skills. **\#LI-Remote** **\#LI-NITINMAHAJAN** IQVIA is a leading global provider of clinical research services, commercial insights and healthcare… more
- Interstate Blood Bank (Research Triangle Park, NC)
- …Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being ... services in more than 110 countries and regions. The Director of Business Development - Cell Therapy will drive...focus on human biological raw materials, cell sourcing, and regulatory compliance in cell therapy processes. This role requires… more
- Ferguson Enterprises, LLC. (Raleigh, NC)
- …coordination and diplomacy across multiple functional areas. + Functional knowledge of global regulatory requirements for consumer and commercial products. + ... a **Senior Director - Quality and Product Assurance** . This global role is responsible for the Company's product assurance, compliance, and quality programs,… more
- Edwards Lifesciences (Raleigh, NC)
- …their span of influence/control The Sr Manager, Biostatistics Level is lateral to Associate Director , Biostatistics (" Associate Director Biostatistics") ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Lilly (Durham, NC)
- …a focus on Automated Warehouse operations. This role reports directly to the Associate Director Quality - DAP and Warehouse. The Quality Assurance Representative ... travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations required Eli Lilly and Company, Lilly USA, LLC and our… more