- J&J Family of Companies (Spring House, PA)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory ... people can reach their potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a highly experienced … more
- J&J Family of Companies (Spring House, PA)
- Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory ... Authorities. + Provides technical expertise and technical input in the preparation and writing (as applicable) of regulatory dossiers for submission to Health… more
- Organon & Co. (Plymouth Meeting, PA)
- …support the approved early development plans. The TMED Lead will serve as the medical monitor and/or study director responsible for the execution (in conjunction ... **The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will be responsible for… more
- Teva Pharmaceuticals (West Chester, PA)
- …results and provide a guidance to prepare high quality reports working with Medical Writing + Responsible for authoring protocol synopses and working with ... (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Senior Director will provide... Medical Affairs and provides input and direction to the… more
- Merck (North Wales, PA)
- …lead clinical scientist on the clinical trial team. + Collaborates with the Medical Writer on clinical/scientific and regulatory documents. + Partners with Study ... of clinical data/ medical protocol deviations in collaboration with the Clinical Director . + Builds talent and capabilities of direct and indirect team members… more
- Genesis Healthcare (Wayne, PA)
- …pay classification, job grade, location, and length of service. The Assistant Recreation Director is responsible for assisting the Recreation Director in the ... to the development of program philosophies and policies, along with writing procedures, goals and objectives for the program.*Contribute to the implementation… more
- Organon & Co. (Plymouth Meeting, PA)
- …promotional regulatory strategy in collaboration with Commercial, PRT, Global Regulatory Liaisons, Medical Affairs and Worldwide Product Labeling. + Guide ... writing ability, effective communication and familiarity with worldwide regulatory agencies. + Experienced in negotiations with health authorities. + Outstanding… more
- IQVIA (Wayne, PA)
- …Publications, Medical & Scientific Communications** **Agency Equivalent: Senior Scientific Director , Publications** In concert with the medical leads, the ... crafting a strategically relevant poster for a congress, or writing a target journal outreach email, this candidate will...Advisor will interface with all stakeholders, from clients to medical leads, senior management to medical writers,… more
- J&J Family of Companies (Spring House, PA)
- …such as nonclinical safety, pharmacokinetic, and discovery biology project leaders, medical writers, global regulatory dossier leaders, and other subject ... Skills:** **Required:** + Experience working globally as lead author on writing Toxicology, Pharmacology, Pharmacokinetics, or Bioanalytical regulatory documents… more
- Pfizer (Collegeville, PA)
- …study team in governance meetings and submissions, partners with/supports the Development lead/ Medical Director regarding study and disease area strategy. + ... **ROLE SUMMARY** The Late-Stage Clinical Scientist (non-MD, Director ) is responsible for scientific oversight, data integrity and quality of clinical trial(s) in… more
- University of Pennsylvania (Philadelphia, PA)
- …Myeloma Research Team and indirectly report to the CRU Central - Associate Director of Clinical Research Operations. The successful candidate will work closely with ... of the team's work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to...The candidate will work closely with the CRU Associate Director of Operations to develop and implement SOP's, report… more
- CSL Behring (King Of Prussia, PA)
- …drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs). **BENEFITS** + Medical , Dental Vision + 401K ... around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines...or Bern Switzerland office. You will report to the Director of Global Clinical Science Lead. **Responsibilities:** + You… more