- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overseeing multiple program-level CS Asset Leads who are managing a team of clinical scientists for the writing of protocols / amendments and associated ... investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Level: Requires 9+ years of relevant experience. Minimum of 8 years clinical /regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Experience Level: 7+ years of relevant experience Minimum of 5 years clinical /regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...Senior Medical Writer reports to a Director of Medical Writing . The Senior Medical Writer is expected to develop… more
- Merck & Co. (North Wales, PA)
- …to the needs of audiences across cultures and communities.Background in medical writing , authoring ICH clinical documents (ie, Informed Consents, Protocols, ... Job DescriptionThe Medical Writing & Disclosure Department of the GCTO organization...a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical documents.Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, potential collaborations ... and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical documentsParticipate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, potential collaborations ... rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality… more
- Merck & Co. (North Wales, PA)
- …work under the guidance and direction of a Principal Scientist/Medical Writing Director to prepare journal articles, conference abstracts, and posters/oral ... presentations that report results of Company clinical trials or other scientific work. Preparation of these materials includes organizing kick-off calls, writing … more
- SafeBeat (San Francisco, CA)
- …Business Leadership, and Forming Strategic PartnershipsProficient in Technical/Scientific Writing / Clinical OperationsProficient in Analytical and Critical ... in the MedTech industry, hospital systems, and device companies.Facilitating clinical trial progression (eg patient recruiting/pilots, data collection, publication… more
- Invivyd (Boston, MA)
- …Interactions. Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departments, leading the ... but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and potentially international… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post ... registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study ... of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... concerns to management and relevant team members.Reports and Submissions: May contribute to writing minor safety sections of the NDA, CSR, and IB. May review any… more
- Infosys Limited (Hartford, CT)
- Principal Consultant - Clinical Data Management Infosys is seeking Principal Consultant with Clinical data management experience. As a Principal Consultant, you ... Technology experience. At least 6 Years' experience in End-end Clinical trial management process and related applications. Experience in...platforms preferably in pharma IT space. A basic knowledge writing custom queries in SQL or PL/SQL is needed… more
- IGM Biosciences, Inc. (Mountain View, CA)
- … clinical operations, manufacturing, commercial, finance, procurement, and IT.Experience writing and presenting clearly on supply topics.Must be highly motivated ... About IGM Biosciences, Inc.IGM Biosciences (Nasdaq: IGMS) is a clinical -stage biotechnology company committed to developing and delivering a new class of medicines… more
- Arcellx (Redwood City, CA)
- …less experience may be considered at the director level. Proficiency directly writing submission documents that support clinical trials, marketing applications, ... Who We Are Arcellx isa public, clinical -stage biotechnology company reimagining cell therapy by engineering...How You'll Make a Difference As our Senior Director, Clinical Regulatory Affairs, you'll lead and drive Arcellx's … more
- athenahealth (Boston, MA)
- …accessible, high-quality, and sustainable healthcare for all.Senior Product Manager, Clinical Services WorkflowsThe OpportunityYou will fill a critical role in ... will work daily within scrum leaders to ensure effective definition and writing of user stories, prioritizing product backlogs, and making trade-off decisions… more
- CLevelCrossing (San Francisco, CA)
- …Regulatory Affairs will support the company mission by overseeing the following functions: Clinical Regulatory CMC Regulatory Medical Writing In this role, the ... other Clinical or CMC Regulatory Affairs personnel, Regulatory Medical Writing , Quality Assurance and Pharmacovigilance and Drug Safety functions. Grow and… more
- Massachusetts General Physicians' Organization (Boston, MA)
- …available.Publish journal articles and present work at computer science and clinical conferences.Participate in grant writing and preparation.Work closely with ... multidisciplinary and collaborative environment, consisting of neurologists, computer scientists, clinical trials experts, and drug development teams, from varied… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network ... medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from… more
- Famous Footwear (San Francisco, CA)
- …specialty rotations. Residents will start with an intensive boot camp to shore up clinical basics as well as EMR training, an orientation to practice management and ... will continue to receive trainings and preceptorship to continue to enhance their clinical practice. Second year residents will also serve as mentors for first year… more
