- Merck & Co. (North Wales, PA)
- …and their results, document disclosure, and data sharing with external researchers. - The Director , Informed Consent Medical Writer (ICMW) is responsible ... for studies of varying complexity across therapeutic areas. Oversee work of other informed consent medical writers, providing scientific and operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …profile Develop and update the minimum mandatory safety text (MMST) for use in the Informed Consent Own the safety sections of the labelling for the evolving ... Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs) Establish and ensure deliverables to/from Data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brochures (IB) Responses to requests from regulatory agencies and ethics committees Informed consent and assent forms Lay summaries of clinical trial ... plans, study designs, and regulatory submissions. Relationships The Principal Medical Writer reports to a Director of...The Principal Medical Writer reports to a Director of Medical Writing. The Principal … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …protocols and protocol amendments Clinical study reports (CSR) Investigator brochures (IB) Informed consent and assent forms Lay summaries of clinical trial ... and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The Senior Medical … more
- Merck (Columbus, OH)
- …trials and their results, document disclosure, and data sharing with external researchers. The Director , Informed Consent Medical Writer (ICMW) is ... requirements, and health literacy principles. The responsibilities of the Director ICMW are to: + Produce high-quality and timely...complexity across therapeutic areas. + Oversee work of other informed consent medical writers, providing… more
- CSL Plasma (Loiza, PR)
- …the Quality Assurance Team. Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, which includes preparation ... cell immunizations are given. Submits monthly report to Divisional (or Corporate) Medical Director . + Determines donor suitability following adverse reactions in… more
- Walgreens (Deerfield, IL)
- **Job Description:** **Job Summary** Walgreens RWE Clinical Trials is seeking an experienced Medical Director role to provide medical oversight and ... activities to win new clinical trials for the business. Major duties of the Medical Director are outlined below: **Job Responsibilities:** + ** Medical … more
- CSL Plasma (Cheektowaga, NY)
- …the Quality Assurance Team. Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, which includes preparation ... cell immunizations are given. Submits monthly report to Divisional (or Corporate) Medical Director . 12. Determines donor suitability following adverse reactions… more
- The Walt Disney Company (Santa Monica, CA)
- …Learning to Extended Reality. Disney Entertainment & ESPN Technology is seeking a Director , Product Management - Data Governance & Privacy to lead high visibility ... support data management, access management, policy enforcement, sensitive data detection, consent management and more. This team captures behavioral and technical… more
- United Therapeutics (Silver Spring, MD)
- …Development team within Unither Bioengineering. This role also serves as primary Medical Director support for Lung Bioengineering. This position is located ... protocols, study design, and scheduled assessments. Review and approve all versions of informed consent form templates. Review serious adverse events (SAEs) and… more
- Ascendis Pharma (Princeton, NJ)
- …the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, ... a dynamic workplace for employees to grow and develop their skills. Medical Safety Science Director reports to Head of Global Medical Safety Science. Under… more
- CSL Plasma (Tucson, AZ)
- …of the Quality Assurance Team. Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff. 7 Responds to inquiries ... to determine a donor's initial and continued suitability for plasmapheresis, explaining informed consent materials to donors. JOB SPECIFICATIONS Provide minimum… more
- Hartford HealthCare (New Britain, CT)
- *Associate Medical Director - General Psychiatry - New Britain, CT* *Hartford HealthCare's Behavioral Health Network (HHC BHN), has* *new opportunity available ... to prescribing practices that are safe and evidence based. Obtains appropriate and informed consent for medications trials prior to prescribing. . Acts as… more
- ThermoFisher Scientific (Orlando, FL)
- …depend on - now and in the future.** Summarized Purpose for the Medical Director -Investigator: Serves as the investigator on all assigned clinical trials ... providing medical oversight for a particular protocol and client. Ensures...in FDA Form 1572, including, but not limited to informed consent and screening examinations of subjects,… more
- Kedplasma (Augusta, GA)
- …and in accordance with SOP, FDA, PPTA, OSHA, CLIA, cGMP by utilizing informed consent administration, assessing medical history, and administering physical ... for donor safety and welfare through donor history and physical examinations, informed consents, management of donor reactions, evaluation of laboratory results and… more
- Bristol Myers Squibb (Princeton, NJ)
- …trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical ... work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area… more
- Amgen (Washington, DC)
- …for a career you can be proud of. **Global Safety Officer (GSO),** **Global Safety Medical Director - Obesity** **, US - Remote** **Live** **What you will do** ... Core Safety Information (core data sheet, core risks in informed consent forms, etc.) + Prepare/review core...**Basic Qualifications:** MD or DO degree from an accredited medical school AND Completion of an accredited medical… more
- BeiGene (San Mateo, CA)
- The Executive Medical Director will support BeiGene Clinical and Medical assets within the Hematology franchise by successful development of early and late ... the job:** + Protocol concepts, synopses, and amendments + Informed consent documents + Investigator Brochures +...selection of investigator and vendors + Provide scientific and medical support throughout conduct of a clinical trial; respond… more
- BeiGene (Emeryville, CA)
- **General Description:** The Senior Medical Director , Hematology will support BeiGene Clinical and Medical Hematology assets by successful execution of ... area, molecule, and/or clinical protocol + Provide scientific and medical support throughout conduct of a clinical trial; respond...+ Review, query, and analyze clinical trial data + Informed consent documents + Investigator Brochures +… more
- YAI (Visalia, CA)
- …not limited to: Incident Review Committee, Human Rights Committee, Informed Consent Committee, Clinical Rounds, Referral and/or Agency Director Meetings. + ... required. + Attends appropriate trainings and forums to keep informed of all newly proclaimed, modified and existing codes,...+ Coordinates with Clinical Director and Regional Director for administrative guidance regarding medical needs… more
