- Merck & Co. (Rahway, NJ)
- …quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of ... and maintenance of financial systems. Financial forecasting in conjunction with Sr .COM /other roles.Executes and oversees clinical trial country submissions… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... medicine.Accountable for the operational planning, feasibility, and execution of a clinical protocol.- May lead team in key study planning, development and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **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… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …clinicians in hematology, immunology, neurology, and transfusion medicine. Main Job Scope of the Sr . Clinical Study Mgr role: To manage the end to end (protocol ... study recruitment and retention materials, in conjunction with any partner CRO project manager . + **Delivery of Clinical Trial** - Includes set-up, maintenance… more
- AbbVie (Waltham, MA)
- …our Quality Team, willing to work in close collaboration with the Clinical , Regulatory, Translational Science, and Pharmacovigilance departments to ensure ... a group setting and to interact effectively with internal customers, including Clinical , Medical and Pharmacovigilance functions. + Strong communication skills… 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. ... of SDTM, presentation of data in table and listing, and visualization for clinical safety monitoring requirements. Works closes with other functional groups such as… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is true to the best of my knowledge. **Job Description** **Job Description for Senior Medical Director, Clinical Science, Marketed Products Development** As the ... Director Marketed Products (SMDMP) you will report to the Head of Global Clinical Science, Marketed Products Group and are accountable for Medical Sponsor and … more
- Merck (Columbus, OH)
- …quality standards and adverse event reporting requirements internally and externally. Our Clinical Research and Pharmacovigilance team push the boundaries of ... maintenance of financial systems. Financial forecasting in conjunction with Sr .COM /other roles. + Executes and oversees clinical...address and resolve issues, with minimal support from the Sr .COM or manager . + Ability to make… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The role of Senior Clinical Program Leader (CPL) - Retinal health, assumes full medico-scientific and strategic leadership of clinical ... integrates as chairperson the output of cross-functional evidence team ( Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory,… more
- BeiGene (Emeryville, CA)
- …departmental activities **Supervisory Responsibilities:** + The position has no direct reports. The Senior Manager , Safety Scientist is part of a team that ... + 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. ... on real-world evidence, and creating hope for all facing illness. The Senior Managerwill support signal detection activities and medical analyses to support… more
- Amgen (Washington, DC)
- …patients worldwide. It's time for a career you can be proud of. **Global Safety Senior Manager , Hematology Oncology - US Remote** **Live** **What you will do** ... portions of periodic aggregate safety reports (eg PBRERs, DSURs). + Support clinical trial-related activities: provide support and oversight to staff with regards to… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Senior Manager , Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... Development role. Strong Expertise with transferable skills related to Good Clinical Practice(GCP), and/or Good Pharmacovigilance Practice (GVP). Does this… more
- Merck (North Wales, PA)
- **Job Description** 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 efficacy...and close out visits + Experience as a CRA Manager , Lead CRA or Project Manager + Rare… more
- Sanofi Group (Cambridge, MA)
- …treatment to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty ... therapies and when they are not eligible to participate in a clinical trial. Cross-GBU Pre-Registration Import License (PRIL) is designed to oversee temporary… more
- Merck (Columbus, OH)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential ... Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of… more
- AbbVie (North Chicago, IL)
- …development and accountable for complying with those requirements. Serves as a senior clinical representative for key regulatory discussions. + Ensures adherence ... disease area and platform level. + Acts as a senior -level liaison for opinion leader interactions related to the...to Good Clinical Practices, pharmacovigilance standards, standard operating procedures… 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 ... The incumbent is expected to be a strong people manager and be willing to 'roll up the sleeves'...clinical programs. + Ability to work with the Senior Executive Team and other external audiences such KOLs,… more
- AbbVie (Boston, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of Safety Statistical Programming is a strategic role in the emerging ... the statistical programming activities for development and maintenance of integrated clinical safety data for multiple compounds and indications. The Manager… more
- Bristol Myers Squibb (Chicago, IL)
- …and payers. The RD position is also responsible for working closely with senior management to create and execute medical initiatives at a national level. This ... or cross-therapeutic teams that have national impact **b. External Expert Manager ** + Maintains strong knowledge of regional and national External Experts… more
