- 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 ... Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory Submissions, Strategic Thinking,… more
- Merck & Co. (Rahway, NJ)
- …and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience with ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design… more
- Merck & Co. (Upper Gwynedd, PA)
- …technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (eg, manufacturing, formulation and process development, ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise in Lean ... a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …redesign and SOP authoring/coordination (Required)3 or more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... technical writing, and presentation skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical , clinical drug development, project management, and/or medical field… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ... treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Associate III as part of the Technical ...of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position Support the operations and execution of affordability programs across the Diabetes, Obesity and Rare Disease ... Market Access, Legal, and Compliance to establish and monitor the program operations and related forecasts for affordability programs. Works with key internal… more
- Eisai, Inc (Nutley, NJ)
- …role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... operations components. Key Responsibilities:Manage and oversee the clinical operations function, ensuring compliance with GCP and regulatory … more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations , Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical , Biologic, and Vaccine Products. Our team works with a "Safety… more
- Eisai, Inc (Exton, PA)
- …and close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to cGMP, ... Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and...to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and… more
- Merck & Co. (Rahway, NJ)
- …the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS).- Education Minimum Requirements:- ... Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations .Current… more
- Merck & Co. (Rahway, NJ)
- …Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause ... DescriptionAs a Technical Lead, you will report into Director, Chemical Technical Operations , External Manufacturing API Technology, and play a pivotal role in… 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
- AUROBINDO (Durham, NC)
- …group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of ... organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management… more
- Merck & Co. (Rahway, NJ)
- …mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage ... and presentation skills - Education/Experience Bachelor's Degree +5 years of pharmaceutical , clinical drug development, project management , and/or medical field… more
- Merck & Co. (North Wales, PA)
- …specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... PowerPoint, Word, Outlook, etc.)Education/Experience: Bachelor's Degree +5 years of pharmaceutical , clinical drug development, project management, and/or medical field… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced ... 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)
- …college/universityRequired Experience and Skills:Relevant work experience in chemical, pharmaceutical , large molecule, or vaccine process development, including the ... and Skills:Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development… more
- Tris Pharma (Monmouth Junction, NJ)
- …responsible for multiple facets of the Procurement function within a pharmaceutical manufacturing environment including, but not limited to, purchasing, sourcing, ... small team to develop and implement procurement strategies and operations , contract negotiations, supplier relationship management, procurement systems functionality/workflows… more
