- Parexel (Washington, DC)
- …and approved programs, helping to shape the future of life-saving therapies. As a **CMC Regulatory Affairs Senior Associate ** , you will play a critical role ... discipline (advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. + Proven… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... ( Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule… more
- Merck & Co. (Rahway, NJ)
- …the Final Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps them informed ... studies, and occasionally Good Laboratory Practice (GLP) studies. The Associate Principal Scientist is the primary clinical ...and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory … more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities ... clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- BeOne Medicines (Emeryville, CA)
- …clinical trial, real-world and post-marketing surveillance data. + Partner with regulatory affairs teams to establish and monitor competitive landscapes, ... functions to define KPIs, OKRs, metrics as pertained to pharmacovigilant and regulatory affairs , develop and implement role-based dashboards or analytical tools… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical ...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Title: Senior Manager, Clinical Affairs Job Description Summary: The Senior Clinical Research Associate will report to the Associate Director, ... $110000.00 Salary Description Job Title: Senior Associate , Clinical Research Supervisor/Manager...key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory… more
- Stony Brook University (Stony Brook, NY)
- Clinical Research Associate II **Required Qualifications (as evidenced by an attached resume):** Bachelor's Degree (foreign equivalent or higher).Three (3) years ... **Preferred Qualifications:** Five (5) or more years' experience in clinical trials and regulatory compliance. Bilingual in...of posting.** **Job Number:** 2503665 **Official Job Title:** : Clinical Research Associate II **Job Field** :… more
- Merck & Co. (Boston, MA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… more
- Eisai, Inc (Nutley, NJ)
- … Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical ... international regulatory /ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these external as… more
- Insmed Incorporated (NJ)
- …QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC ... or practices from external labs.Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs , Supply Chain, and other departments to ensure… more
- Insmed Incorporated (San Diego, CA)
- …will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.What ... technical expertise and system documentation.Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development.Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily… more
- Programmable Medicine Operatin (Redwood City, CA)
- … Operations, Clinical , Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and collaborating ... Programmable Medicine, a clinical stage biopharmaceutical company located in Redwood City, is seeking an experienced individual to focus on leading our contract… more
- Stony Brook University (Stony Brook, NY)
- Postdoctoral Associate **Required Qualifications:** (as evidenced by an attached resume) Doctoral Degree (or foreign equivalent) in Chemistry or a closely related ... Emission Tomography (PET) research. **Brief Description of Duties:** The Postdoctoral Associate will join PET research core at Stony Brook University. Primarily,… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** We are currently recruiting for an Associate Director, Peer-to-Peer Education & Health Care Provider (HCP) Activation for ... will report to the Director, US Dermatology Brand Marketing Strategy. The Associate Director, Peer-to-Peer Education & HCP Activation will lead the development and… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The role of Associate Director, Dermatology Outcomes Research Epidemiology and Economics will report to the headquarters ... Director of Medical Affairs Outcomes Research. Focusing on Dermatology, in this role, you will be responsible for establishing/continuing economic Modelling research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... or for any project with CDPs containing multiple registrational clinical trials and are extensively exploring the predictive nature...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Alameda Health System (Oakland, CA)
- …Imaging in interdepartmental initiatives involving IT, Quality, Education, Compliance, and Regulatory Affairs . **DUTIES & ESSENTIAL JOB FUNCTIONS:** NOTE: The ... team, responsible for providing strategic oversight of department-wide education, clinical competencies, quality assurance, regulatory compliance, PACS/RIS… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820,… more
Related Job Searches:
Affairs,
Affairs Associate,
Associate,
Clinical,
Clinical Regulatory,
Clinical Regulatory Affairs,
Regulatory,
Regulatory Affairs,
Regulatory Affairs Associate