- Merck & Co. (Philadelphia, PA)
- …of patient reported outcomes, epidemiological studies and economic modeling.The Associate Principal Scientist also works closely with Product Development Teams, ... Franchise Teams, Regional Product Directors, our company's affiliates, Public Affairs , and Medical Education to ensure value evidence programs are consistent with… more
- Merck & Co. (Upper Gwynedd, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... development projectsAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate… more
- GRAIL (Trenton, NJ)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- CSL Behring (King Of Prussia, PA)
- Associate Director, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Associate Director, Corporate and External Affairs , R&D ... Relationships:** + **Reports to:** Head of Corporate and External Affairs , R&D + **Direct reports to position:** 1 **Main...and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities,… 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 will ... this role you will be reporting in to the Senior Director of Commercial Business Analytics Reporting & Data...use cases) In close partnership with ABCIA Commercial, Medical Affairs , and Market Access teams to ensure solutions are… more
- CSL Behring (King Of Prussia, PA)
- …the guidance of the Publications Director, you will partner with Medical Affairs leaders, Compliance, Clinical, HEOR, and other functions to build efficient ... SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication...and enhance our scientific impact globally. As a more senior member of the publications team, you will also… more
- CSL Behring (King Of Prussia, PA)
- …required data collection and submit all reports needed for compliance. 4. Work with Senior Director, Policy Advocacy & Government Affairs , & Legal to interpret ... of biotech/pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other… more
- Parexel (Trenton, NJ)
- …FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the ... and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of… 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 will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- University of Pennsylvania (Philadelphia, PA)
- … Regulatory Job Description Summary With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of ... clinical research undertaken within the department/division. The Associate Director for Regulatory Affairs assists the Director in providing direction and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- United Therapeutics (Philadelphia, PA)
- …communication with teammates and appreciate the opportunity to collaborate with senior management, CPLs, MSL Field Directors, MSLs, Medical Communications and ... (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to develop/execute disease… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Associate Director, Scientific Communications manages the execution of...consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:**… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- J&J Family of Companies (Spring House, PA)
- …of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related field. An advanced degree is preferred. ... **We are searching for the best talent for an Associate Director, Submission Program Management Lead to be located...SPML will be a key partner to the Global Regulatory Leader (GRL), Compound Development Team Leader (CDTL) and… more
- Merck (North Wales, PA)
- …of patient reported outcomes, epidemiological studies and economic modeling. The Associate Principal Scientist also works closely with Product Development Teams, ... Franchise Teams, Regional Product Directors, our company's affiliates, Public Affairs , and Medical Education to ensure value evidence programs are consistent with… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Tax Attorney ( Associate General Counsel) Job Profile Title Associate General Counsel Job ... investment taxation, and will be comfortable navigating the nuanced regulatory frameworks applicable to mission-driven institutions with sophisticated investment… more
- J&J Family of Companies (Spring House, PA)
- …biomarker discovery, translational research, computer vision, clinical development, medical affairs , diagnostics, regulatory , and commercial teams to assess ... https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine is recruiting an ** Associate Director, Oncology AI Biomarkers & Diagnostics** to join… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality ... **Job Summary** The Associate Director, Quality Operations will lead initiatives that...on key risk indicators and escalate critical risks to senior leadership. **Global Quality System Processes** + Oversee the… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
