- Novo Nordisk Inc. (West Lebanon, IN)
- …investigation report contains the technical merit and completeness according to regulatory expectations. The Deviation Investigator- Writer will be responsible ... Are you ready to realize your potential? The Position The Deviation Investigator- Writer is responsible for investigating and writing of deviations to the… more
- Eisai, Inc (NJ)
- …Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer , the ... as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and review marketing application submission documentsAt the Director's… more
- Tris Pharma (Monmouth Junction, NJ)
- …clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality ... (KOLs), clinical trial investigators and internal scientific, pharmacology and regulatory teamsReviews data generated during study execution to formulate medical… more
- Merck & Co. (North Wales, PA)
- …clinical scientist on the clinical trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager ... on study deliverables.Participates in the set up and design during study start up (eg, database set up)Lead medical monitoring team in review and interpretation of clinical data/medical protocol-deviations in collaboration with the Clinical Director.Builds… more
- Citigroup (Tampa, FL)
- The Regulatory Response Writer Senior Lead is a strategic professional who closely follows latest trends in own field and adapts them for application within own ... experts to inform these documents. + Oversee and manage key regulatory interactions (quarterly progress reports, formal examinations, on-going supervisions, ad-hoc … more
- Capgemini (Richmond, VA)
- **Job description:** Capgemini Engineering is looking for a Technical Writer to work closely with Regulatory compliance team in an Agile environment for ensuring ... 100% regulatory compliance alignment) within the consumer products domain! **Key...US by Capgemini. **Job:** _Developer_ **Organization:** _ERD PPL US_ **Title:** _Technical Writer - FDA Regulatory_ **Location:** _VA-Richmond_ **Requisition ID:**… more
- Adecco US, Inc. (Bridgewater, NJ)
- …onsite at Bridgewater, NJ and few days for the first few months) Duties The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory ... position papers, and briefing book. In parallel, the technical writer could help support non regulatory writing...the technical writer could help support non regulatory writing projects such as SOP and technical documents… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …Social Science Support - Positions may include: Biostatistician; Clinical Data Manager/ Regulatory Writer ; Quality Assurance Officer; Regulatory Scientist; ... Regulatory , Clinical, and Technical Clinical Trial support Location...Technical Writer ; Program Manager; Biomedical Science Writer ; Principal Investigator. + Medical Services - a .… more
- Abbott (St. Paul, MN)
- …a Senior Clinical Evaluation Reporting / Medical Writer (CER). The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic ... Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related documentation. + Evaluates and… more
- Novo Nordisk (West Lebanon, NH)
- …investigation report contains the technical merit and completeness according to regulatory expectations. The Deviation Investigator- Writer will be responsible ... Are you ready to realize your potential? The Position The Deviation Investigator- Writer is responsible for investigating and writing of deviations to the… more
- Abbott (Santa Clara, CA)
- …fingersticks. **The Opportunity** The function of a **Senior Medical Writer /Project Manager** supporting our Structural Heart Clinical Evaluation Products combines ... device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices...2.7/1 Rev 4) and EU Regulation 2017/745. The CER Writer /PM is recognized as a subject matter expert for… more
- Medical Mutual of Ohio (OH)
- …Cleveland, Ohio area residents preferred._** **Responsibilities** **Healthcare Analyst- Policy Writer ** + **Researches and analyzes evidence and background materials ... may include identification of specialty society positions, identification of regulatory findings specific to technologies, identification of coding specific… more
- MicroVention, Inc. (Tustin, CA)
- …years of scientific experience. 3. Demonstrated experience in the development of regulatory / clinical submissions (preferably as a medical writer for ... **12078BR** **Title:** Sr. Medical Writer **Job Description:** **INNOVATION STARTS WITH YOU** Are...job duties include: + Collaborating with the clinical & regulatory teams to write clinical documents for regulatory… more
- System One (Baxley, GA)
- System One is seeking a Technical Writer for a fully remote, 6-month contract position. This role will support our client in the nuclear industry by assisting with ... procedure updates and enhancements. Technical Writer Responsibilities: + Review and analyze procedure change assignments, typically provided as redlined PDF… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12251BR** **Title:** Sr. Medical Writer (PhD or MD) **Job Description:** **INNOVATION STARTS WITH YOU** Are you interested in working for an organization that is ... **TERUMO** has to offer. **Position Overview** The Sr. Medical Writer /Medical Writer will act as primary contact...job duties include: + Collaborating with the clinical & regulatory teams to write clinical documents for regulatory… more
- Charles River Laboratories (Charleston, SC)
- …Summary** **Charles River Labs based in Charleston, SC is seeking a Technical Writer 2 for our Research & Development Engineering team.** Technical writers plan, ... to the overall success of our products and services. As a Technical Writer for the Microbial Solutions Research and Development team, you will be collaborating… more
- The Arc Oneida-Lewis Chapter (Utica, NY)
- Our Plan Development Team is seeking a Plan Writer to join their team in Oneida County! In this role you will be responsible for overseeing the plan of services ... delivered to each assigned person we support. The Plan Writer works with the person and their support team...Action Plans are disseminated to the Care Manager within regulatory requirements and agency procedures. + Ensure all appropriate… more
- ThermoFisher Scientific (Juneau, AK)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Senior Medical Writer (North America) (FSP; Remote)** At Thermo Fisher Scientific, you ... North America. We are looking for a Senior Medical Writer to be dedicated to a client in the...the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. + Ensures compliance… more
- IQVIA (Ithaca, NY)
- We are seeking a **Medical Writer ** to join Q2 Solutions, IQVIA's laboratory business **Remotely.** We hire passionate innovators who drive healthcare forward ... us as we transform and accelerate research and development. As a Medical Writer , you will contribute to the preparation of pharmacokinetic (PK) method validation and… more
- M&T Bank (Clanton, AL)
- **Overview:** The Technical Writer will collaborate directly with our model developers and will play a key role in creating and maintaining high-quality technical ... of data analysis, technical specifications, statistical approaches, business use cases, regulatory guidelines as well as governance and internal controls to ensure… more
