- Lilly (Boston, MA)
- …preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADERS), ... better for people around the world. **Position Summary:** The Associate Vice President (AVP), Women's Health & Early Clinical...ability to progress new medicines as part of a drug development team. Responsibilities of the role include directing… more
- Sanofi Group (Morristown, NJ)
- … interactions, quantifying benefit-risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle ... **Job Title:** Associate Director Quantitative Data Modeling **Location:** Morristown, NJ...planning. + Good knowledge of industry best practices, global regulatory , processes, standards of drug development. **Demonstrate… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …(written and verbal) with demonstrated use of domestic (ie Food and Drug Administration CFR) and applicable foreign regulatory agency requirements/guidelines + ... packaging, and warehousing of plasma related products. The Principle Quality Compliance Associate will support hosting external audits and will support and lead… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission ... regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for… more
- Organon & Co. (Jersey City, NJ)
- …authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as applicable. The Associate Director, Biopharmaceutics will ... **Job Description** **The Position** The Associate Director, Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of … more
- Emory Healthcare/Emory University (Atlanta, GA)
- …and commonly used HIV/AIDS drugs in the world. **Are you ready?** The Associate General Counsel's duties will include: Regulatory Compliance: + Advise on ... seeks a health care attorney with significant transactional and regulatory experience to join its talented legal team as...experience to join its talented legal team as an Associate General Counsel. The Associate General Counsel… more
- The Boeing Company (Everett, WA)
- …The Boeing Regulatory Administration & Airworthiness team is seeking an ** Associate (Level 2) or Experienced (Level 3) Certification System Technical Writer** to ... of experience levels including Mid-Level and Senior Technical Writer. The Regulatory Administration & Airworthiness Enterprise Certification Processes team is hiring… more
- Lilly (Pleasant Prairie, WI)
- …solutions that impact the site and align with corporate objectives. The Associate Director, Quality Assurance, will also provide computer system quality assurance ... in operational processes, and Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment. The Site Data Leader is… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …inspire you and empower you to shine? Join us as an Associate Medical Director, Clinical Science, Neuroscience- Pulmonologist/Neurologist in our Cambridge, MA ... a vital contributor to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for the overall global… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director, Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale ... biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role… more