- 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- ThermoFisher Scientific (Cranbury, NJ)
- …food is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs , you will play a crucial role in interpreting ... for global requirements and desired marketing claims. + Author and/or review regulatory submissions , specifically device master files, regulatory support… 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
- 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency ... The Manager , Medical Core Content is a team-level operational...Veeva Vault, to manage content lifecycle and Medical Review submissions . + Track and report content usage and effectiveness,… 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
- Eliassen Group (Trenton, NJ)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager , Med Device, R&D PMO, Design Changes** **Anywhere**...and industry regulatory standards. * Exposure to Regulatory submissions and Operations/manufacturing interfaces. * Background… more
- Sumitomo Pharma (Trenton, NJ)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... software + Ability to evaluate and write case reports and prepare regulatory submissions + Analytical thinking and attention to detail + Communication skills for… 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... core scientific lexicon and messaging, ensuring its consistent application across all Medical Affairs materials through clear guidance to the Manager of Core… 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)
- …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
- Merck (West Point, PA)
- …biologics and vaccines. The role also requires extensive engagement with Manufacturing, QA, Regulatory Affairs , and Supply Chain. The ideal candidate should have ... + Implement/maintain LIMS, ELN, and analytics for decision-making and regulatory submissions . + Represent BCR in executive...biologics. Must have at least 5 years as a manager in a supply focused team (ie critical reagents,… more
- University of Pennsylvania (Philadelphia, PA)
- …coordinator activities such as: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions . Communicate with study ... submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the… more