- 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
- Contribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or between Pharmaceutical Development & Commercialization, Inc. and a 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 OPDC 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
- 3-5 Years experience in Drug Safety with Similar Task
- Experience with single case unblinding
- Knowledge with early development activities and documents (phases 1-2)
- Immunology experience
- Must be an MD or DO
- 12-month contract, open to 12+ month extension
- 2 Video Interviews - Start 2-3 weeks from an offer
- Full time, 40 hours/week
- Hybrid – Onsite 2 days a week onsite (Tuesday and Wednesday)
- Benefits available (Medical, Dental, Vision, 401k)
- Salary: K
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Drug Safety Physician
3 weeks ago
GForce Life Sciences Princeton, NJ, United StatesThe 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 documents · Contribute to writing and r ...
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Drug Safety Physician
3 weeks ago
GForce Life Sciences Princeton, United StatesThe 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 documents · Contribute to writing and revi ...
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Drug Safety Physician
2 weeks ago
Clinical Resource Network (CRN) Princeton, United StatesOur client is looking to fill the role of Drug Safety Physician. This role will be hybrid and based out of the Princeton office. · Responsibilities: · Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, s ...
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Director, Safety Surveillance Physician
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Johnson & Johnson Horsham, United StatesJohnson & Johnson, is recruiting for a **Director, Safety Surveillance Physician (Oncology) **to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA. · We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of ...
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Global Safety Physician
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ADC Therapeutics SA New Providence, United StatesApply · Job Type · Full-time · Description · Global Safety Physician · New Providence, NJ/Hybrid/Remote · Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people ...
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Medical Records Representative Part Time
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United Surgical Partners International Inc (USPI) Princeton, United States Part time**Job Summary**: Maintains and reviews the medical records to assure the timely completion and proper authentication of all records. Safeguards the medical records while making them readily accessible at all times. · **Essential duties and responsibilities**: Include the followin ...
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Certified Home Health Aide
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TheKey Princeton, United StatesOverview: · **Location**:Princeton, Plainsboro, West Windsor, East Windsor, and surrounding communities. · Must have an active Certified Home Health Aide (CHHA) license in the state of New Jersey · **TheKey** provides premier in-home senior care to help older adults thrive at hom ...
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Penn Medicine Princeton, United States Full time**Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...
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Vp, Late Clinical Development Oncology
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Bristol-Myers Squibb Princeton, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
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Cert Med Assist-receptionist
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Penn Medicine Princeton, United States**Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...
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Associate Ii Regulatory Labeling
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TK-CHAIN LLC Princeton, United States**SUMMARY OF POSITION** · The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submi ...
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Medical Receptionist
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Medical Receptionist
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Penn Medicine Plainsboro, United States**Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...
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Patient Services Associate
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Medical Receptionist
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Mri Tech Per Diem
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Social Worker
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Merwick Care & Rehabilitation Center Plainsboro, United StatesAssists with planning and implementing a comprehensive social services program which provides for counseling and other support services for residents and families in the facility; · - Identifies medical-related social needs of residents, provides appropriate services to meet the ...
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Mental Health Associate
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Dining Coordinator
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Patient Access Associate Ed Ip Njs
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Drug Safety Physician - Princeton, United States - GForce Life Sciences
Description
The Project Physician tasks may include:
Requirements:
Term & Start
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