- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Specialist , Quality Management Systems and Compliance reports to the Director, Animal Health Quality Management Systems and Compliance ... reports and provide PQC data /line listings to US Regulatory Affairs for inclusion in Drug Experience Reports to...inclusion in Drug Experience Reports to be submitted to regulatory authorities including the US FDA.- -Support global manufacturing… more
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist , Project Manager is a core member of Early Drug ... develop strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily ... interaction with manufacturing, quality, IT, and engineering groups. - The Senior Specialist for Manufacturing Automation is responsible for providing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Boulder, CO)
- …improvements that reduce risk and cost to the overall operation. Relationships Specialist , API Manufacturing reports to the Senior Manager, API Manufacturing. ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Merck & Co. (Rahway, NJ)
- …outsourced vendors relationships in your area. Interact and manage expectations of senior business users and stakeholders. Ensure that DP team is delivering in ... accordance to our Company's regulatory commitments, sustainability requirements and highest standards of quality. Coordinate and work closely with other work streams… more
- Merck & Co. (Rahway, NJ)
- …produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist , Associate Director, is a subject matter expert in CDISC ... with Health Authority regulations and guidance and company best practices.The Vocabulary Specialist is able to:Work independently, collaboratively as a member of a… more
- Novo Nordisk Inc. (Boulder, CO)
- …with all applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters in MA. Internal relationships ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global function on study and project teamsProduces independent writing for publications & regulatory documentsServes as a specialist in PK-PD and Pop PK-PD ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global function on study and project teamsProduces independent writing for publications and regulatory documentsServes as a specialist in PK-PD and Pop PK-PD ... function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and… more
- ICF (Reston, VA)
- …the DC Metro area) with flexibility for telework considered. **Job Responsibilities:** The Senior Regulatory Specialist will employ strong research, policy ... small teams of staff to work toward a milestone or deliverable. The Senior Regulatory Specialist will work within and help manage interdisciplinary teams… more
- ICF (Los Angeles, CA)
- Description Senior Regulatory Specialist Southern CA We are the Environment & Planning Division. We are passionate about doing what's right for our clients, ... Southern California Natural Resources Team is looking for a an experienced Regulatory Specialist to support permitting needs, including preparing permit… more
- Rincon Consultants (CA)
- Rincon Consultants, Inc. is seeking a ** Senior Regulatory Specialist / Project Manager** who will be responsible for delegating and overseeing workflow and ... + Serving as Rincon's primary Project point of contact for the client and regulatory agencies + Technical direction to staff and subcontractors + QA / QC Business… more
- J&J Family of Companies (Columbus, OH)
- Senior Regulatory Affairs Specialist - 2406173183W **Description** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory ... has a proven track record for growth, integrity and innovation. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to… more
- ConvaTec (Lexington, MA)
- …about Convatec, please visit http://www.convatecgroup.com **Job Summary:** In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be ... Technologies division's global regulatory strategies and processes. The Senior Regulatory Affairs Specialist will drive compliance, mentor colleagues,… more
- Stryker (Tempe, AZ)
- …annually. More information is available at www.stryker.com We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our **Sustainability ... and meets regulations and expectations. **What you will do** As the Senior Regulatory Affairs Specialist for Stryker Sustainability Solutions, you will… more
- Stryker (Mahwah, NJ)
- …about our award-winning organization by visiting stryker.com We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our Joint ... and launched with precision. **What you will do** As the ** Senior ** **R** **egulatory Affairs Specialist ** , you will evaluate the regulatory environment… more
- Stryker (Cary, IL)
- …and industry trends for sales, management and leadership teams. **What you will do** As a ** Senior Staff Regulatory Specialist ** , you will be exposed to a ... information is available at www.stryker.com We are currently seeking a ** Senior ** **Staff Regulatory Affairs Specialist ** to join our **Medical Division** .… more
- Kelly Services (Cuyahoga Falls, OH)
- Kelly Science & Clinical is seeking a ** Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH.** **Direct Hire** **Shift:** Monday - Friday 8am-5pm ... based on experience **Responsibilities:** + Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific ... Procedures (SOPs), and study specific protocols/plans and processes. The Sr Regulatory Compliance Specialist position maintains documentation for clinical… more
