- Merck (North Wales, PA)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...regulatory strategy for their assigned products, in order to optimize… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC...strategy and assessing the quality of documents for regulatory submissions to major market health authorities as well… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will...and regulatory leadership in defining the global regulatory strategy for biosimilar (BioS) projects. You… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory ... encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions,… more
- J&J Family of Companies (West Chester, PA)
- …* Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... Senior Director , DePuy Synthes, Medical Affairs , TECA...and omni-channel insights to help shape optimal business development strategy and targets, including product launches, key scientific meetings,… more
- J&J Family of Companies (Spring House, PA)
- …Medical Affairs programs/activities globally. **Key Responsibilities:** Develop Global Medical Affairs strategy and plan for the assigned compounds based on ... Global Medical Affairs Leader, Director , Dermatology - 2406179906W...Excellent knowledge of study execution, benefit risk management and regulatory affairs . + Proven ability to act… more
- J&J Family of Companies (Spring House, PA)
- Director , Patient & Site Engagement and Feasibility - Medical Affairs - 2406191573W **Description** ** Director , Patient & Site Engagement and Feasibility - ... Medical Affairs ** At Johnson & Johnson, we believe health is...inspire innovation in patient and site journey mapping, engagement strategy creation, and trial feasibility analysis, aligning these efforts… more
- Pfizer (Collegeville, PA)
- …Product Team(s). As a Director , Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from ... Achieve** You will represent Pfizer as anApprovalLiaison in the regulatory affairs team. You will play the...the GRST, develop, align, manage and implement the global regulatory strategy . Be accountable for: + Delivering… more
- J&J Family of Companies (Spring House, PA)
- …**Required:** + 10 years in global pharmaceutical/biotechnology industry + 3 years in regulatory affairs or related field + Experience in business support and ... Director , GRA Strategy & Planning -...global, and heavily regulated environment + Basic understanding of regulatory affairs policies/guidelines and processes, and global… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Patient Engagement Strategy - 2406191859W **Description** Johnson & Johnson is recruiting for an **Associate Director , Patient Engagement ... enrich the healthcare experience for all. As the Associate Director of Patient Engagement Strategy within IHE&A,...to ensure a comprehensive understanding of our risk and regulatory frameworks. + Evaluate current processes and practices within… more
- Pfizer (Collegeville, PA)
- …medical processes, appropriate SOP's, working with key stakeholders, to support strategy and execution of Medical Affairs , data generation/communication ... **ROLE SUMMARY** The Vaccines Operational Excellence Director role is an integral member of the...category-led initiatives that have an impact on multiple Medical Affairs stakeholders and markets. They combine organizational, project management,… more
- J&J Family of Companies (Spring House, PA)
- …profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Global Regulatory Affairs business technology team is focused on providing ... technology solutions to help drive J&J Innovative Medicine's Global Regulatory Affairs organization, we are currently seeking...external service providers. The IT Sr. Manager, TPM for Regulatory Excellence will report to the IT Director… more
- J&J Family of Companies (Spring House, PA)
- …in the pharmaceutical industry * Experience in Clinical development, clinical operations, regulatory affairs , or patient advocacy in large complex organizations ... Director , Clinical Research Equity - 2406191866W **Description** Johnson...Clinical Trials (DEICT) leads on setting the overall DEI strategy and goals for J&J Drug development, to ensure… more
- Teva Pharmaceuticals (West Chester, PA)
- …as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, ... key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the… more
- J&J Family of Companies (Spring House, PA)
- …quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs , clinical supplies unit, medical writing, clinical ... pharmacology, legal, finance, quality assurance, strategy and operations, global medical affairs , health...Committee (IDMC) and adjudication meetings as needed. + Assists Regulatory Affairs in determining requirements for any… more
- Merck (North Wales, PA)
- …within Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director , Medical Operations, ... regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges… more
- CSL Behring (King Of Prussia, PA)
- The Associate Director of US Market Access - New Products will lead US value, access, pricing, and reimbursement strategy in preparation for the launch of ... areas of transplant and cardiovascular. Responsibilities will include value strategy , evidence development, payer messaging, channel and distribution planning,… more
- J&J Family of Companies (Spring House, PA)
- …in the pharmaceutical industry * Experience in Clinical development, clinical operations, regulatory affairs , or patient advocacy in large complex organizations ... Director , Clinical Research Equity - Community Engagement -...(GD) and the enterprise to communicate a coherent, aligned strategy across all levels of the organization. This role… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Director may… more
- Organon & Co. (Plymouth Meeting, PA)
- …of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.). + At least ... **The Position** We are looking for two experienced Associate Director , Program & Project Managers to join our team....to contribute to the development of the overall program strategy and objectives for achieving the target product profile… more