- Lundbeck (North Hyde, SD)
- … pharmaceutical regulations (eg, TGA, FDA, EMA) and assess their impact on business operations . You will provide support and guidance in the interactions between ... will act as the Legal and Compliance Ambassador throughout the organisation. Provide support and consultancy to the company and the Management Team on compliance… more
- Merck & Co. (Rahway, NJ)
- …an Associate Director, IP Docket Management to provide docketing and legal operations support to the Intellectual Property (IP) organization. Primary ... and timely entered in the docketing system in accordance with US and international patent law and procedure. This position has a flexible hybrid office schedule… more
- Capital One (New York, NY)
- …including integrated audits. Perform risk assessments of business units and technology operations , design and execute audit procedures to verify the effectiveness of ... oral presentations. Identify expectations of the client and take actions to support the client experience. Prepare clear, organized and complete documentation to … more
- Insmed Incorporated (NJ)
- …possible for patients with serious diseases. Reporting to the SVP, Technical Operations , you will lead all Chemistry, Manufacturing, and Controls (CMC) activities ... will serve as a key member of the Technical Operations leadership team and contribute significantly to our overall...Ensuring compliance with ICH, FDA, EMA, PMDA and other international regulatory guidelines will be essential to your success.You… more
- Formation Bio (New York, NY)
- …to drive successful drug product development and manufacturing operations .Responsibilities Technical Leadership: Provide technical leadership for development and ... chain, etc) quality assurance, regulatory, clinical pharmacology and project management to support short and long term program objectives. CRO and CDMO Management:… more
- Eisai, Inc (Exton, PA)
- …manufacturing steps per production scheduling, material staging, equipment set-up, and GMP operations in the Biologics Operations group. The Sr. Manufacturing ... connections within team to achieve goals and solve problems.Essential Functions:Provide hands-on support and/or some leadership in the operation of equipment to … more
- Aequor (Northborough, MA)
- …product vials as finished product for sale and distribution to US, European and International markets in support of a global patient population. In the process ... Description: Department Description: The Packaging group, located at the Northborough Operations Center facility, is responsible for labeling and packaging of final… more
- Tris Pharma (Monmouth Junction, NJ)
- …anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US We also ... believe in each other and in respectful, open and honest communications to help support individual and team success.We have an opening in our Monmouth Junction, NJ… more
- Tris Pharma (Monmouth Junction, NJ)
- … Operations , Research and Development (R&D), Finance, etc.) to support purchasing controls/budget and a comprehensive procurement strategy aligned with ... addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in...and in respectful, open and honest communications to help support individual and team success.We have an opening in… more
- Repligen (Waltham, MA)
- …chromatography coupled with analytical problem-solving and customer-facing skills.ResponsibilitiesCustomer Support & TroubleshootingServe as the technical point of ... in collaboration with Quality, Engineering and OperationsProvide technical troubleshooting support during customer qualification, validation and manufacturing runsApplication and… more
- Genmab (NJ)
- …by providing approved disease and product information, resources, and support to key decision-makers and stakeholders within the assigned ... geography.ResponsibilitiesEffectively support Genmab's Solid Tumor Oncology portfolio in the US marketplace, focusing on customers within the Pittsburgh… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence ... strategic planning and portfolio execution of key work in support of Centers of Excellence for the packaging and...components and packaging master data and systems.The Packaging Technical Operations organization aims to be an industry leader in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with cross-functional teams including Facilities, Finance, HR, Quality and Operations to ensure engineering support broader organizational goals. ... Biotech is seeking Associate Director, Engineering as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Director of Engineering… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Be responsible for the ... setting with quality counterparts that include Quality Assurance, Manufacturing Operations , and Analytical/Process Development.Job duties performed require routine exposure… more
- Genmab (Berkeley Heights, NJ)
- …we would love to have you join us!Patient Access CoordinatorJob Overview:The Patient Support Services Patient Access Coordinator (PAC) will be a support role ... Call Center. This role will focus on key areas of Patient Services operations and workforce management including, but not limited to:Call Quality Monitoring &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …various company initiatives and functions such as Marketing, IT, Clinical, Research, Operations , Patient Support Programs, and Digital Health Lead cross ... purpose of the Legal Counsel - Corporate Law role is to provide legal support , advice, and strategic counsel to Novo Nordisk US Affiliate stakeholders, with a focus… more
- Eisai, Inc (Pittsburgh, PA)
- …and participation in strategic thinking. Essential Functions Product/Therapeutic Area Support to External Stakeholders Act as the primary clinical/scientific ... products and relevant therapeutic areas to population-based decision-makers, as requested. Support assigned professional congresses in accordance with MSL plan. Be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard ... Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Key focus is on… more
- Novo Nordisk Inc. (Boulder, CO)
- …all clinical drug product manufacturing including process characterization activities to support commercialization for nucleic acid programs and will have thorough ... Functions Lead, manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved… more
- Insmed Incorporated (NJ)
- …channels in PAH.Oversee tactical planning, sequencing, KPIs, and execution to support TPIP adoption at launch.Collaborate with global and regional colleagues to ... with Legal, Regulatory, Compliance, Medical Affairs, Market Access, and Commercial Operations team members to align and compliantly execute key tactical… more
