- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Merck & Co. (Rahway, NJ)
- …Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root ... matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in… more
- Eisai, Inc (Nutley, NJ)
- …training, marketing, managed markets, sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Eisai, Inc (Boston, MA)
- …decision-making within local markets and healthcare systems).Experience working with pharmaceutical manufacturer compliance & regulatory ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in… more
- Merck & Co. (Rahway, NJ)
- …Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital ... Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling,… more
- Merck & Co. (Rahway, NJ)
- …Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance , Reviewing Literature {+ 4 more}-Preferred Skills:Job ... leading a team for a common goal-Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical,… more
- Merck & Co. (Rahway, NJ)
- …selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once ... Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS).- Education Minimum Requirements:- Bachelor's… more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics and authoring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise in Lean Manufacturing, Six Sigma, and continuous… more
- Eisai, Inc (Nutley, NJ)
- …relations, government price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and ... support, patient assistance programs, adherence support).Works to ensure Eisai's compliance with pharmaceutical laws and industry guidelines including… more
- Merck & Co. (Rahway, NJ)
- …or related field with a minimum of 8 years of experience in the pharmaceutical industry, MS in analytical chemistry/biochemistry or related field with a minimum of ... 12 years of experience in the pharmaceutical industry, or BS in analytical chemistry/biochemistry or related field with a minimum of 16 years of experience in the … more
- Lundbeck (Edmond, OK)
- …Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory… more
- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage… more
- Merck & Co. (North Wales, PA)
- …Risks, Life Science, Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance , Regulatory Documents, Science {+ 4 ... specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance , Regulatory Reporting, ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
