- Merck & Co. (Upper Gwynedd, PA)
- …science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology ... Clinical Research Group. Under the guidance of a supervisor, the Senior Director has primary responsibility for the planning and directing of clinical research… more
- Merck & Co. (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems...industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
- Merck & Co. (Montgomery County, PA)
- …described in the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Merck & Co. (Upper Gwynedd, PA)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be ... and manufacturing to manage clinical development projectsAssist the Senior Director , Associate Vice-President/Vice-President and Product Development Team Lead… more
- CSL Behring (King Of Prussia, PA)
- The Associate Director , Commercial Data Science & AI is crucial in driving the overall strategy for (Gen)AI tools and technologies within CSL. This individual ... solutions. In this role you will be reporting in to the Senior Director of Commercial Business Analytics Reporting & Data Science. Lead development and deployment… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **Position Overview** The Associate Director is responsible for ensuring that Primary Market Research, Competitive Intelligence, and Data ... and procedures, and governing body rules and standards. The Associate Director will: + Be a champion...project workflows in core markets. + Support the Executive Director with internal audits, regulatory inspections and… more
- Organon & Co. (Plymouth Meeting, PA)
- …INDs, briefing books and other regulatory documents, as applicable. The Associate Director , Biopharmaceutics will be the primary author for module 2.7.1 ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert...responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** We are looking for an experienced Associate Director , Program Manager to join our team. This successful candidate will ... in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs, etc.) + At least three years of experience in… more
- CSL Behring (King Of Prussia, PA)
- The Associate Director , Vendor Governance is responsible for establishing and leading a new CoE focused on external service provider/vendor operational ... enable transparency, accountability, and alignment with enterprise strategy and regulatory expectations. **Main Responsibilities & Accountabilities:** Governance Framework Development… more
- Organon & Co. (Plymouth Meeting, PA)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is ... responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing ... in accordance with global regulations and?guidance, and?Organon procedures.? The Associate Principal Scientist will lead the?preparation and submission of CMC… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The role of Associate Director , Dermatology Outcomes Research Epidemiology and Economics will report to the headquarters ... Director of Medical Affairs Outcomes Research. Focusing on Dermatology,...priorities. Developing and implementing patient-centred endpoints strategies, working with regulatory , Value Strategy Assessment (VSA's) and contracting. The role… more
- CSL Behring (King Of Prussia, PA)
- …collection and submit all reports needed for compliance. 4. Work with Senior Director , Policy Advocacy & Government Affairs, & Legal to interpret and implement ... of biotech/pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other… more
- CSL Behring (King Of Prussia, PA)
- …well as expertise in cross-functional collaboration. This position will report to the Associate Director , Contract Execution and will work closely with other ... Legal and Compliance to ensure all contracts comply with relevant regulatory requirements and standards, including state and federal healthcare regulations +… more
- Parexel (Trenton, NJ)
- …success, we are expanding our esteemed Medical Sciences Team and seeking an Associate /Medical Director to support the growth of our Global Immunology and ... Inflammation Therapeutic Franchise. As an Associate / Medical Director , you will work...including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and… more
- BeOne Medicines (Pennington, NJ)
- …+ Manage and coordinate global change ensuring stakeholders alignment. Assist in Regulatory filings and Health Authority site inspections to license and maintain ... and lifecycle process improvements. + Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing. + Ability to work both independently… more
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Associate Director , Regulatory Job Profile Title Associate ... Job Description Summary With the oversight of the Director , the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader… more
- J&J Family of Companies (Spring House, PA)
- …We are searching for the best talent for a **Senior Manager/ Associate Director ** , ** Regulatory Medical Writing** within ... Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area. **The position can be located...+ Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to ... interpret the impact of regulatory changes to the pharmaceutical environment. **Job Description** +...+ Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated regulations… more
