- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that foster a reputation for outstanding quality, collaboration, rigor, and follow-through. Collaborate with the Head Global RD PV QA and the Head Global ... function heads for effective decision-making, and present to the Global Head of RD, PV QA/Vice President...to ongoing activities. Produce and deliver accurate reports and documentation related to Global QA activities in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …levels are met.Lead the process for reviewing and assessing KQIs regularly, preparing management documentation for the QA Head , and ensuring that any gaps or ... or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas of Medical… more
- Merck & Co. (Rahway, NJ)
- …solid-oral small molecules and includes pre-approval regulatory strategy and submissions ( global clinical and marketing applications such as IND, CTA, ... and traditional solid-oral small molecule products and including pre-approval regulatory work ( global clinical and marketing applications such as IND, CTA, NDA,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... for correction, with a copy to manager and department head .Provide timeline to address issues and verify that issues...systemAdvise speaker bureau vendor to provide all back up documentation ( ie F&B receipt, AV, sign in sheet,… 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 ... management activities within US Patient Safety Team. Relationship Reports to the Head of NNI Patient Safety, with cross-functional working relationships within Case… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Clinical Documentation Global Head **Location** : Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... be critical in helping our teams accelerate progress. The Clinical Documentation Head is responsible...management strategies and flawless execution of Clinical Documentation deliverables. We are an innovative global … more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Head , BioAnalytics, CMC Development **Location** : Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race ... and sustainable, and our products accessible and convenient. The Global Head of BioAnalytics is responsible for...& Supply, Business Development). **Scope of the Role** + ** Clinical Stages:** From engaging with Research to selecting the… more
- Abbott (Alameda, CA)
- …a significant impact on people's lives. **The Opportunity** Lingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative ... Abbott is a global healthcare leader that helps people live more...EU MDR) and oversee internal and external audits. + Documentation and Submissions: Manage the preparation and submission of… more
- Boehringer Ingelheim (Fulton, MO)
- …equipment documentation . + Skillfully collaborates and cooperates within the global teams performing studies where parasites are needed which includes internal ... and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering… more
- Teva Pharmaceuticals (West Chester, PA)
- …in Global Regulatory Medical Writing, may write and edit clinical regulatory documents, including submission summaries and other complex documents, provides a ... Director, Therapy Area Head , Medical Writing Date: Sep 6, 2025 Location:...for the direct medical-writing support in the production of clinical research documentation used in drug development… more
- Takeda Pharmaceuticals (Boston, MA)
- …on regional specificities within Therapeutic Area. **ACCOUNTABILITIES:** + Accountable to Oncology Clinical Science Head to provide strategic clinical input ... on assigned clinical studies. + Leads the Global Development Team (US, EU, and others) managing both...trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are… more
- Astellas Pharma (Northbrook, IL)
- …in the Immuno-Oncology group. + Reports to the Medical Lead/disease area strategy head for the given program(s) and is accountable for defining the strategy and ... execution of assigned trials. + Clinical team leader with clear understanding of areas of...and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events. + Coordinates with Safety… more
- General Dynamics Information Technology (Portsmouth, VA)
- …Required:** NACI (T1) **Job Family:** Science and Research **Skills:** Clinical Study Protocols,Research Activities,Research Protocols **Experience:** 2 + years of ... **Job Description:** GDIT's Military Health team is seeking a Clinical Research Coordinator (CRC) to support the Combat Trauma...studies or IACUC animal studies. + Supports the Department Head of CID and is accountable for research related… more
- Insight Global (Belmont, CA)
- …* Speech-Language Pathologists (SLPs) * Occupational Therapist (OT; current open position) * Head of School * Clinical Care Coordinator Our school is founded ... environments to promote student success and engagement. * Work collaboratively with Clinical Care Coordinator, Head Teacher, Assistant Teacher, Aides, SLPs,… more
- Genentech (South San Francisco, CA)
- …Team, where applicable, and sharing collective leadership with the Country Head , Clinical Operations Excellence Leader(s), Analytics and Performance Leader, ... This role involves close collaboration with the US Country Head and US Leadership Team to ensure that the...drive efficient study start-up processes, facilitating the delivery of clinical trials to patients. This includes enabling innovative … more
- Sanofi Group (Morristown, NJ)
- …alignment with, but not limited to, commercial/marketing, public affairs, finance, clinical , and global teams during planning and execution. _Medical ... and Key Results (OKRs) and impact metrics in close coordination with SEI Head , and global /local leadership + Proactively identify and mitigate potential issues… more
- Glenmark Pharmaceuticals Inc., USA (Mahwah, NJ)
- …and coding of clinical safety events (eg SAEs). + Applies Good Clinical Practices in documentation of phone, electronic, and/or fax correspondence regarding ... the Job This role reports to the Regional Pharmacovigilance Head - North America. The successful individual will be...America. The successful individual will be part of a Global team implementing and maintaining a PV system that… more
- Sanofi Group (Morristown, NJ)
- …with members of the CTT and Project Team, as well as colleagues within Clinical Documentation . + must provide dedicated scientific authoring expertise to ensure ... regarding both the project as a whole, and individual clinical studies. **Our Team:** Global Medical writing...mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with… more
- ConvaTec (Lexington, MA)
- … clinical data management processes and drive organizational growth. + Collaborate with Head of Clinical Operations and other key members (as needed) to ... Develop and maintain data management and data analytics study documentation , including (but not limited to) clinical ...on time and within budget. + Collaborate with the Head of Clinical Operations (and Clinical… more
- Bristol Myers Squibb (Indianapolis, IN)
- …apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of ... a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** RayzeBio is seeking a dynamic and… more
