Project Physician II

2 weeks ago


Princeton, United States Advanced Clinical Full time
OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a Project Physician in Princeton, NJ. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES
  • Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documents
  • Experience with single case unblinding
  • Knowledge with early development activities and documents
  • Contribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or between Sponsor and CRO
  • Serve as the primary medical contact for assigned trial.
  • Provide oversight of medical monitoring activities and medical surveillance activities of CRO
  • Participate in the evaluation and oversight of clinical trial safety surveillance activities
  • Contributes to the review of draft and final clinical trial tables and listings
  • Contributes to the review of draft and final clinical study reports
  • Participates in the analysis of study data and in post-hoc analyses
  • Participates and contributes to the designated product Safety Governance meetings and other routine interactions with Pharmacovigilance
  • Reviews and contributes to product-wide aggregate report documents, e.g., IB, DSUR, PSURs, annual reports and other similar documents as assigned
  • Performs signaling activities including review of medical/scientific literature, and contribute to safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, and ensure prompt assessment and communication of confirmed safety signals
  • Active contribution to internal and external forums (e.g., DMC, Advisory Boards)
  • Develops and implement Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS)
  • Contributes to product label development, scientific regulatory responses, coding review and approval.
  • Contributes to oversight and provides guidance to medical review of individual case safety reports (ICSRs) for investigational and marketed products
  • Contributes to scientific and medical publications, posters and presentations as needed
EXPERIENCE
  • 3-5 Years experience within Drug Safety

    EDUCATION
  • MD (Doctor of Medicine) or DO (Doctorate of Osteopathic Medicine) required


JOB ID# 509360

  • Princeton, United States Blue Star Partners LLC Full time

    Job DescriptionJob DescriptionJob Title: Administrative Assistant IILocation: Princeton, NJPeriod: 06/10/2024 to 12/31/2024 – Strong potential for extensionHours/Week: 40 hours Rate: $25/hour (Hours over 40 will be paid at Time and a Half)Contract Type: W-2Scope of Services:The Administrative Assistant II is responsible for supporting department managers...


  • Princeton, United States WinnCompanies Full time

    You lead best by getting your hands dirty with your team. Your incredible customer service skills make you a great example and role model. Are you ready to step into a leadership role while maintaining high standards of any property you work on? WinnCompanies is looking for a Maintenance Supervisor II to join our team at The Alice, a brand-new market-rate...


  • Princeton, United States United Global Technologies Full time

    Job DescriptionJob DescriptionMechanical CAD Designer IIMain CAD resource for all mechanical disciplines (NSTX-U, LTX, Flare and other collaboration projects) within the CAD group of the Engineering Division. Core Duties: 5% - Support the PEMP goals.60% - Design, create, modify, and maintain parametric 3D models and 2D models using ProE, SolidWorks and/or...


  • Princeton, United States United Global Technologies Full time

    Mechanical CAD Designer IIMain CAD resource for all mechanical disciplines (NSTX-U, LTX, Flare and other collaboration projects) within the CAD group of the Engineering Division. Core Duties: 5% - Support the PEMP goals.60% - Design, create, modify, and maintain parametric 3D models and 2D models using ProE, SolidWorks and/or CATIA.10% - Verify drawing...


  • Princeton, United States Dale WorkForce Solutions Full time

    Client: Pharmaceutical CompanyPosition: People Operations Analyst IILocation: Remote (EST hours)Duration: 18 month contractRole Description: The People Operations Analyst tasks include:• Partners with HR Operations (Total Rewards, HRIS, and Payroll) and Talent (Talent Management, Talent Acquisition, and Performance Management) to ensure life cycle...


  • Princeton, United States TekWissen LLC Full time

    Job DescriptionJob DescriptionOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is committed to developing new treatments and patient solutions in Neuroscience, Digital Innovation and Nephrology. Our client consists of multiple companies committed to offering innovative products...


  • Princeton, United States TekWissen LLC Full time

    Job DescriptionJob DescriptionOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is committed to developing new treatments and patient solutions in Neuroscience, Digital Innovation and Nephrology. Our client consists of multiple companies committed to offering innovative products...


  • Princeton, United States Techlink Systems Full time

    Job DescriptionJob DescriptionJob Title: Administrative Assistant IILocation: Princeton, NJ (onsite)Contract Duration: Contract until 12/31/2024Work Hours: 8:30am - 5pmDescription: This position is NonExempt. Hours over 40 will be paid at Time and a Half. Requires proficiency in two to three vendor software programs. Provides support to one or two...

  • Drug Safety Physician

    4 weeks ago


    Princeton, United States GForce Life Sciences Full time

    The Project Physician tasks may include:Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documentsContribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or...

  • Drug Safety Physician

    4 weeks ago


    Princeton, United States GForce Life Sciences Full time

    The Project Physician tasks may include:Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documentsContribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or...

  • Sr Actuary

    5 days ago


    Princeton, New Jersey, United States Munich Re Full time

    We're adding to our diverse team of experts and are looking to hire a Senior Actuary to enrich our Transformation, Operations and Processes team within Corporate Reserving.The responsibility of Corporate Reserving is to use quantitative and qualitative methods to perform and oversee the loss reserve analyses for Munich Re's property and casualty business in...

  • Sr Actuary

    1 month ago


    Princeton, United States Munich Re Full time

    We're adding to our diverse team of experts and are looking to hire a Senior Actuary to enrich our Transformation, Operations and Processes team within Corporate Reserving.The responsibility of Corporate Reserving is to use quantitative and qualitative methods to perform and oversee the loss reserve analyses for Munich Re's property and casualty business in...

  • Sr Actuary

    4 weeks ago


    Princeton, New Jersey, United States Munich Re Full time

    Sr Actuary - Systems & Process Specialist Company Munich Re America Services Location Princeton , United StatesWe're adding to our diverse team of experts and are looking to hire a Senior Actuary to enrich our Transformation, Operations and Processes team within Corporate Reserving.The responsibility of Corporate Reserving is to use quantitative and...

  • Sr Actuary

    1 month ago


    Princeton, United States Munich Re Full time

    Sr Actuary - Systems & Process Specialist Company Munich Re America Services Location Princeton , United StatesWe're adding to our diverse team of experts and are looking to hire a Senior Actuary to enrich our Transformation, Operations and Processes team within Corporate Reserving.The responsibility of Corporate Reserving is to use quantitative and...


  • Princeton, United States Dale Workforce Solutions Full time

    Role Description: Strategic Operations Specialist, Pharmaceuticals Summary: This role will report to the People & Business Services (PBS) Chief of Staff Office, supporting strategic operations and executive communications initiatives. This individual will support a wide range of initiatives, both planned and ad-hoc, in managing operationally, story building,...

  • Program Manager III

    4 weeks ago


    Princeton, United States Tandym Group Full time

    A medical services company in New Jersey is looking to add a new Program Manager III to their growing team. In this role you will assist in the following activities under the direction of Senior Program Manager:Develop a robust timeline and plan for the overall program.Development or improvement of program processes to drive program efficiencyUpdate program...

  • Program Manager III

    1 month ago


    Princeton, United States Tandym Group Full time

    A medical services company in New Jersey is looking to add a new Program Manager III to their growing team. In this role you will assist in the following activities under the direction of Senior Program Manager:Develop a robust timeline and plan for the overall program.Development or improvement of program processes to drive program efficiencyUpdate program...

  • Program Manager III

    5 days ago


    Princeton, United States Tandym Group Full time

    A medical services company in New Jersey is looking to add a new Program Manager III to their growing team. In this role you will a ssist in the following activities under the direction of Senior Program Manager: Develop a robust timeline and plan for the overall program. Development or improvement of program processes to drive program efficiency ...

  • CQV Process Engineer

    4 weeks ago


    Princeton, United States Azzur Group Full time

    DescriptionCQV Process Engineer Level II - III Description: Azzur Group is looking for CQV Process Engineers in the surrounding Philadelphia area for New Facility consulting projects. Current project locations include Central Jersey, Philadelphia, and the Lehigh Valley area. This is a great opportunity to expedite your career growth through exposure to...


  • Princeton, United States Advanced Clinical Full time

    OVERVIEW We are currently searching for a skilled professional to join a well-known client's team as a REMOTE Program Manager. The Program Manager role will provide EU MDR Program Management Support . Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES ...