- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Writing team. Relationships The Director Medical Writing (Director) reports to a Senior Director of Medical Writing. A key focus of this leadership role will ... provide leadership on local and global project teams. This role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is ... and other cross-functional and regional stakeholders.Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in… more
- Eisai, Inc (Nutley, NJ)
- …the therapeutic area. Communicate and represent these plans to upper management/ senior leadership within ESI. Continuously update plans and inform stakeholders of ... advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key… more
- Taiho Oncology (New York, NY)
- …with a dynamic and growing Medical Affairs Department. Position Summary: The Senior Medical Science Liaison (Sr. MSL) is a field-facing representative of the ... collaboration with Medical Affairs personnel supports data generation in Investigator -Initiated Trials (IITs) and SL/HCP initiated projects. Facilitates the review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director, Global Medical Affairs (GMA), Gyn Oncology, under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is ... and other cross-functional and regional stakeholders. Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …a leader within the business, he/she is expected to partner with senior cross-functional colleagues to ensure effective product lifecycle management. The incumbent ... publication and congress planReview independent medical education grant and investigator sponsored trial proposals for strategic and scientific qualityMaintain… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …in Oncology.Represent, collaborate, influence and negotiate across the organization with senior stakeholders to provide Medical Affairs inputs for Oncology specific ... to end evidence generation activities, such as Phase IV and Investigator initiated studies.Prior experience supporting IND filing/submission and launch experience is… more
- State of Minnesota (Willmar, MN)
- **Working Title: Labor Investigator Senior ** **Job Class: Labor Investigator Senior ** **Agency: Labor & Industry Dept** + **Job ID** : 77336 + ... **Location** : Various + **Telework Eligible** : Yes + **Full/Part Time** : Full-Time + **Regular/Temporary** : Unlimited + **Who May Apply** : Open to all qualified job seekers + **Date Posted** : 06/07/2024 + **Closing Date** : 06/20/2024 + **Hiring… more
- State of Minnesota (St. Paul, MN)
- **Working Title: Investigator Senior ** **Job Class: Investigator Senior ** **Agency: Public Employment Relations Board** + **Job ID** : 76365 + ... **Location** : St. Paul + **Telework Eligible** : Yes + **Full/Part Time** : Full-Time + **Regular/Temporary** : Unlimited + **Who May Apply** : Open to all qualified job seekers + **Date Posted** : 05/03/2024 + **Closing Date** : Open until filled.… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Senior Research Investigator Job Profile Title Research Investigator , ... Senior Job Description Summary The Research Investigator Sr (SRI) will act in a leadership role,...of manuscripts, and presenting research findings through various forums. Senior Research Investigator must demonstrate the ability… more
