- 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
- Penn Medicine (Philadelphia, PA)
- …leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across ... Blvd. Philadelphia, PA** **Hours: 8hr Days (HYBRID)** **Summary** : + **The Director of Health Justice Transformation** is a unique opportunity to help establish… 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
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Research Project Director Job Profile Title Manager Research Project C Job Description Summary The ... phenomena at both the basic and applied levels. The Lab is led by Director Dolores Albarracin, Ph.D., the Alexandra Heyman Nash University Professor, and the 28th… 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
- Publicis Groupe (Philadelphia, PA)
- …and career development + Provide estimates for SOW development + Work with the Director , Regulatory Review in the development of departmental SOPs + Oversee work ... www.digitashealth.com | Facebook: www.facebook.com/digitashealth| Twitter: www.twitter.com/digitas_health **Overview** The Manager, Regulatory Review is responsible for managing a team of… 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
- Community Legal Services, Inc. (Philadelphia, PA)
- …will also involve collaboratively working with the Managing Attorney of Intake, Deputy Director of Legal Practice, the Director of Law and Technology, Legal ... data and metrics regarding intake and reporting to the Managing Attorney and Deputy Director of Legal Practice. + Assisting the management team in leading change and… more
- University of Pennsylvania (Philadelphia, PA)
- …personnel in the biospecimen process, shipping and inventory to ensure all regulatory , institutional and PAH CRU policies and procedures is followed. This position ... in the development of investigator-initiated trials and have responsibilities in writing the protocol, database creation, data collection sheets, anaylsis and… more
- PCI Pharma Services (Philadelphia, PA)
- …Utilities/Facilities** Department/Group: Quality / Validation Location: Philadelphia Reports to: Director , Validation FLSA Status: Exempt Prepared By: Dennis Gerlach ... the site commercial Validation Manager for any validation overlap. Assures regulatory and any applicable customer requirements are accurately incorporated into PCI… more
- University of Pennsylvania (Philadelphia, PA)
- …will also be responsible for engaging with the Institutional Review Board (IRB), regulatory affairs, and the Office of Clinical Research to generate documents for AE ... capacity. The project manager reports to the Penn FTDC Director (Irwin) and works closely with associated faculty in...responsible for engaging with the Institutional Review Board (IRB), regulatory affairs, and the Office of Clinical Research to… more
- University of Pennsylvania (Philadelphia, PA)
- …is currently comprised of 12 Research Teams that support disease/discipline specific medical oncology cancer programs within the ACC. The Cell Therapy & Transplant ... products and various sponsors. This position will report directly to the Director of Clinical Research Operations and work directly with Physician Investigators… 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
- Wolters Kluwer (Philadelphia, PA)
- …to experience the value of connecting with colleagues. You will report to the Director , Product Management, CP & ESG TeamMate and under the leadership of the SVP, ... Strong communication skills - verbal and written. + Strong understanding of regulatory requirements and industry standards related to risk management and compliance.… more