- J&J Family of Companies (Titusville, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job ... responsible for the operational management and delivery of global clinical trial regulatory submissions . + Create and handle dossier plans/submission packages in… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... and filing 510(k), IDE, PMA submissions , FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely … more
- J&J Family of Companies (Titusville, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** People Leader **All ... way. Learn more at https://www.jnj.com/innovative-medicine We are seeking **Senior Manager , RA Submissions ** to be located Raritan,...+ Bachelor's Degree or higher in Life Sciences, Pharmacy, Regulatory Affairs , or a related field. +… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,...and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... in the biotech or pharmaceutical industry, with exposure to regulatory activities/ submissions and 3 years working on... and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. +… more
- University of Pennsylvania (Philadelphia, PA)
- …to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory ... trials that offer cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs… more
- University of Pennsylvania (Philadelphia, PA)
- …in order to successfully execute and operate the above research protocols ( regulatory submissions and development of key study documents including protocol, ... and much more. Posted Job Title Clinical Research Project Manager B/C Job Profile Title Clinical Research Project ...to successfully execute and operate the above research protocols ( regulatory submissions and development of key study… more
- RELX INC (Horsham, PA)
- …systems and LexisNexis solutions interoperate seamlessly to support compliant labeling, regulatory submissions , and product lifecycle management. Requirements + ... including authoring or reviewing validation deliverables. + Strong understanding of regulatory affairs , quality assurance, product lifecycle management, and data… more
- University of Pennsylvania (Philadelphia, PA)
- …review proposals for compliance with sponsor and University policies and ensure Regulatory Affairs requirements are satisfied and that Conflict of Interest ... and resources, and much more. Posted Job Title Grants Manager A/B Job Profile Title Grants Manager ... will be responsible for multiple monthly pre-award proposal submissions for various PIs. Tasks include managing proposal development,… more
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partnering with Regulatory Affairs in planning, coordination, writing, and execution of ... 510(k), IDE & PMA submissions and approvals + Collaborating with VP, Strategy & Corporate Development to ensure that Globus can attract and retain the best… more
- University of Pennsylvania (Philadelphia, PA)
- …specimens and manage study data and regulatory files per GCP.Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, ... study team.CRC B: With the help of the project manager , manage/coordinate/organize the daily work of research assistants for...such as:Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions .… more
- University of Pennsylvania (Philadelphia, PA)
- …related activities delegated to research coordinator who provides study related support (eg, regulatory submissions and data entry). + May be responsible for ... activities delegated to research coordinators/assistants who provide study related support (eg, regulatory submissions and data entry). May be responsible for… more
- University of Pennsylvania (Philadelphia, PA)
- …complex Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, ... Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research...IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute… more
- University of Pennsylvania (Philadelphia, PA)
- …materials for reports, meetings, presentations, and response to sponsors. 5) Regulatory submissions inclusive of modifications and continuing reviews. Hybrid ... materials for reports, meetings, presentations, and response to sponsors. 5) Regulatory submissions inclusive of modifications and continuing reviews. +… more
- University of Pennsylvania (Philadelphia, PA)
- … submissions to determine the appropriate level of review and triaging submissions to the scientific, statistical reviewer and/or regulatory reviewer as ... Title Coordinator C Job Description Summary Reporting directly to the CTSRMC Manager , the Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator C is… more
- University of Pennsylvania (Philadelphia, PA)
- …and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate including initial submissions , amendments, continuing ... and research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop solutions. Implement… more
- University of Pennsylvania (Philadelphia, PA)
- …and research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop solutions. Implement ... subject recruitment, informed consent, chart maintenance and data entry . Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines . Assure… more
- University of Pennsylvania (Philadelphia, PA)
- …studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical research performed. ... subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating… more
- University of Pennsylvania (Philadelphia, PA)
- …Will problem-solve the challenges to implement a plan of action; will work with the regulatory manager to ensure that submissions to the IRB are completed ... multiple clinical trials. Primary responsibilities will include the following clinical, regulatory and budgetary duties: 1. Clinical: Recruit and assess research… more