- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) ... internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance , Regulatory Affairs, Global Medical and… more
- Merck & Co. (Rahway, NJ)
- …quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of ... global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and...country managers to address and resolve issues, with minimal support from the Sr.COM or manager .Ability to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and External Vendors for the data ... all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development,...process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all… more
- Boehringer Ingelheim (Ridgefield, CT)
- …studies (NIS), Investigator Initiated Studies (IIS), Non Trial Activities (NTAs). Provide support to all functional areas within Global Pharmacovigilance (GPV) ... Responsible for implementing and maintaining global reporting practices for clinical adverse events, including, data collection and delivery, reconciliation and… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …PV Standard Operating Procedures, Work Instructions and Guidance. + Liaise with Global Pharmacovigilance personnel. + Support strategy and project plan for the ... Job Title Pharmacovigilance Intern Requisition JR000014011 Pharmacovigilance Intern...in Webster Groves, MO, and the operations of all clinical and post-marketing adverse event filings to the US… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Senior Manager , Pharmacovigilance (PV) Business Partner Relations in Lexington, MA with ... the following requirements: Bachelor's degree in Clinical , Regulatory Affairs, Pharmacy, or related field or foreign academic equivalent plus 5 years of related… more
- Merck (Columbus, OH)
- …quality standards and adverse event reporting requirements internally and externally. Our Clinical Research and Pharmacovigilance team push the boundaries of ... global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and...country managers to address and resolve issues, with minimal support from the Sr.COM or manager . +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Product Team Lead (EPTL), and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across ... and regulatory aspects of the products to provide medical, clinical and scientific support , mentoring and leadership...& Leadership** + Partner with R&D Marketed Product Project Manager to coordinate R&D function support for… more
- Merck (Columbus, OH)
- **Job Description** **Position Description:** **Associate Clinical Research Manager (aCRM) - Oncology** With support of other Clinical Research ... Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance , Regulatory Affairs, Global Medical and… more
- Johns Hopkins University (Baltimore, MD)
- …Research Site Manager_** who will deliver to and organize work plans with collaborating 20+ clinical sites across the country in support of clinical trial ... teams on schedule with established performance expectations. + Provide support to quality assurance monitors in all facets of...+ Experience in a higher education environment. Classified Title: Clinical Research Site Manager Job Posting Title… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …study recruitment and retention materials, in conjunction with any partner CRO project manager . + **Delivery of Clinical Trial** - Includes set-up, maintenance ... and attending courses/seminars. **Relations/Network** + Interacts internally with Global Clinical Research and Operations, Regulatory Affairs, Pharmacovigilance ,… more
- Merck (Columbus, OH)
- …quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams ... **Job Description** Our Clinical and Pharmacovigilance teams manage studies...Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible… more
- BeiGene (Emeryville, CA)
- …signal detection and signal assessment along with required documentation following BeiGene process ** Clinical Trial Support ** + Conduct review of safety data and ... + Assist with integrated Benefit/Risk assessments **Promote and Advance the Field of Pharmacovigilance ** + Any other tasks assigned by manager to assist in… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. ... evidence, and creating hope for all facing illness. The Manager , Drug Safety Aggregate Reports will function as the...and contract updates related to drug safety vendors and support the logistical management of global safety governance escalation… more
- Sanofi Group (Bridgewater, NJ)
- **Regional PV Manager ** Internal posting title: Deputy Country Safety Head, US and Canada **Location:** Bridgewater, NJ **Remote Work:** Hybrid **Job Type:** Full ... of the CSH. + Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations. +… more
- BeiGene (San Mateo, CA)
- …signal detection and signal assessment along with required documentation following BeiGene process ** Clinical Trial Support ** + Lead the review of safety data ... + Contribute to integrated Benefit/Risk assessments **Promote and Advance the Field of Pharmacovigilance ** + Any other tasks assigned by manager to assist in… more
- Editas Medicine (Cambridge, MA)
- …and pharmacovigilance , and is responsible for protocol development and clinical sections of regulatory documents (e,g. IND submission, briefing documents, study ... position reporting to the Chief Medical Officer will lead clinical development for Editas' expanding clinical portfolio...The incumbent is expected to be a strong people manager and be willing to 'roll up the sleeves'… more
- AbbVie (North Chicago, IL)
- …who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans, ... representative for key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as chairperson the output of cross-functional evidence team ( Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory, ... Brochures (with support from the Medical Writer and other contributors), Clinical Development Plans or similar documents, Core Clinical Trial Protocols,… more
