- Merck & Co. (Rahway, NJ)
- …Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management ... Job DescriptionAssociate Director , Business System Labeling Management Required experience and... Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , … more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Insmed Incorporated (San Diego, CA)
- …program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team ... for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development support testing… more
- Eisai, Inc (Exton, PA)
- …Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of ... your profile, we want to hear from you. The Associate Director of Biologics Operations ...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team… more
- Merck & Co. (Durham, NC)
- …contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for ... ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations , External Manufacturing API Technology, and play a pivotal role ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Merck & Co. (Rahway, NJ)
- …facility in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and ... Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations .Current… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... practices related to clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make rapid, disciplined decisions.… more
- Merck & Co. (North Wales, PA)
- …with partners, vendors, and vendor management team . Review and provide clinical operations input into relevant clinical documents such as the protocol and other ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education is from… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams.Responsibilities: Study Strategy:… more
- Merck & Co. (Durham, NC)
- …questionnaire, blood test, chest x-ray Position Responsibilities:This role reports to an Operations Associate Director and supports the product transfer ... Management Process, Operational Excellence, Process Optimization, Process Troubleshooting, Production Operations , Production Support, Project Management, Regulatory Compliance,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and our tenacity to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting ... the Head of Regulatory Operations in maintaining Rhythm's regulatory submission standards...across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director… more
- Humana (Montgomery, AL)
- …the candidate will be required to work in either Central or Eastern Time. Associate Director , Regulatory Intake Compliance is responsible for enterprise-wide ... operational value and reduces compliance risk exposure for the organization. The Associate Director , Regulatory Intake Compliance will be responsible… more
- Merck (Upper Gwynedd, PA)
- **Job Description** GRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs** , works out of ... RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory ...may consider quality assurance, research and development/support, scientific affairs, operations , or related area. + Note: Higher education may… more
- Merck (Rahway, NJ)
- …Description:** Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management ... **Job Description** ** Associate Director , Business System Labeling Management**... Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , … more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development ... Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved… more
