- Merck & Co. (Lower Gwynedd, PA)
- …not limited to:Represent the PDMB group in early through late product development teams and influence bioanalytical strategies together with stakeholders.Provide ... lead group in complex multiparameter data analysis, interpretation and summary.Author regulatory filings and respond to regulatory authority questions pertaining… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology .Our science and technology make us unique, but our team ... Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But...NJ headquarters has an immediate need for an experienced Product Manager or SR Product Manager. The… more
- Tris Pharma (Monmouth Junction, NJ)
- … technology partnership process: identify promising opportunities and create business case, manage outreach and develop relationships with prospective partners, ... other strategic initiatives. This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC, New Products,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strong cross-functional relationships; checking to ensure compliance to Legal, Regulatory and industry standards; reviewing and analyzing experience data and ... timely messages to customers based on their preferences, behaviors, and product lifecycle stage. Monitor the performance of personalized campaigns and initiatives,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Team leads the US marketing efforts for Novo Nordisk's robust cardiometabolic product portfolio, which includes world class therapies for the treatment of diabetes, ... team, you will contribute to the development and delivery of our portfolio vision, business strategies, and tactical plans that drive our business forward. You… more
- Tris Pharma (Monmouth Junction, NJ)
- …combination across technical (eg, research, product development, clinical development, regulatory , CMC) and business (eg, business development, alliance ... neuroscience and other therapeutic categories employing our proprietary science and technology .We have an immediate opening in our Monmouth Junction, NJ facility… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality ... and analyses clinical trial data and translates data into actionable plans at product levelContributes to Medical aspects of Regulatory issues related to… more
- Fidelity TalentSource LLC (Center Valley, PA)
- …plans, then join a team that is a stable industry leader. Fidelity provides a business model with an existing client base and institutional feeders of business ... brand. We fully support you with an open architecture product platform and top resources in the financial industry,...virtually to help you with all aspects of your business . You will not fail due to a lack… more
- Genmab (Plainsboro, NJ)
- … Authority policies and guidance and correctly apply them as appropriate in product regulatory activities. Ability to influence and partner with cross-site teams ... Scientists, Trial Managers, Scientific Writing, MW Writing,) to support product development strategy Ability to balance multiple tasks to... business acumen and ability to see the business drivers outside of Regulatory Affairs. Excellent… more
- Genmab (Plainsboro, NJ)
- …building quickly to meet the business demand of immediate, real-time AI technology product innovation. Our technology experts tackle exciting challenges ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...fulfilling our purpose. AI & Analytics Products Position Title: Product Owner At Genmab, AI technology is… more
- Genmab (Plainsboro, NJ)
- …IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different ... delivery. In this role, you will collaborate closely with Business to help define product vision and...a technical solution and articulate it back to the business stakeholders. Solid understanding of regulatory guidelines… more
- Genmab (Plainsboro, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... At Genmab, we are evolving the way we do business with digital transformation. At Genmab IT and Digital...and Digital organization we are constantly evolving on our technology landscape to bring better therapy and support to… more
- Genmab (Princeton Junction, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... and oversee creation of clinical components of key documents ( regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting… more
- Genmab (Plainsboro, NJ)
- …and healthcare providers. The focus of this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US Market ... and Compliance team, in particular security architects and Genmab Security Operations Team Business leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM… more
- Genmab (Plainsboro, NJ)
- …for further signal evaluation in a timely manner. . Work with key business partners in developing and implementing product -specific surveillance plans. . ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...detection and analysis of internal company safety data, international regulatory safety databases, and other data sources, eg, claims… more
- Genmab (Plainsboro, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... all levels in the organization, as well as with external parties, including Regulatory Authorities, as applicable. The role reports to the Senior Director MD, Team… more
- Genmab (Plainsboro, NJ)
- …audits and inspections. Interdepartmental Collaboration: Collaborate with Data Science, AI, and business functions to promote a product mindset. Enable ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...highest standards of quality and compliance, adhering to key regulatory guidelines from relevant authorities. This position will be… more
- Genmab (Plainsboro, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... has a global perspective, and you will interact with stakeholders ranging from regulatory authorities and colleagues from Genmab's four sites. You will be part of… more
- Genmab (Plainsboro, NJ)
- …teams with working knowledge across multiple R&D functions (preclinical, clinical, regulatory , CMC) Late-stage clinical development through new product launch ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...VP, Compound Development Team Leader (CDTL) for our antibody product development programs. This is a leadership position within… more
- Larimar Therapeutics (Bala Cynwyd, PA)
- …suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to ... have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good… more
