- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project teams to manage preparation of ... the clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The … more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and review marketing… more
- Aequor (Thousand Oaks, CA)
- Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on ... of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... and CSR safety narratives- May lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the… more
- Lundbeck (Miami, FL)
- …major airport. Territory consists of Florida, Georgia and Puerto RicoSUMMARY: The Senior MSL, Neurology will apply advanced field based medical and scientific ... gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request,… more
- Merck & Co. (Rahway, NJ)
- …trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update ... reports, study close out activities).- Leads team for timeline management, risk identification and mitigation, issue resolution.- May facilitate and collaborate with key internal/external stakeholders (eg, study team, country teams, vendors, committees) in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead/Director/ Senior Director - Safety Surveillance, US ... Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications… more
- Eisai, Inc (Nutley, NJ)
- …and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for working with key ... Essential Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director, work with key stakeholders, management, and functional area… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder the guidance of a Senior Director, Outcomes Research (OR), the incumbent will have the primary responsibilities for developing the integrated ... OR strategies and plans for developmental compounds and obtains cross-divisional senior management approval Critically assess drivers and barriers to reimbursement… more
Related Job Searches:
Claim Investigator Senior,
Fire Investigator Senior,
Investigator,
Research Investigator Senior Scientist,
Senior,
Senior Archaeologist Principal Investigator,
Senior Fraud Investigator,
Senior Internal Investigator,
Senior Research Investigator,
Senior Research Investigator Department