- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... written deliverables that support the clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to… 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
- 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
- BeiGene (San Mateo, CA)
- … Writer -- at a minimum 4 years' relevant industry experience as a regulatory medical writer , plus a BA/BS degree; PhD/PharmD in life sciences preferred. All ... The Senior Medical Writer is responsible for writing, editing, and formatting... is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international … 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
- Novo Nordisk (Plainsboro, NJ)
- …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 written ... deliverables that support the clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a… more
- Novo Nordisk (Lexington, MA)
- …and regulatory requirements of a clinical program. The Medical Writer performs work independently under the supervision of more experienced personnel. ... both worlds to develop new medicines for patients. The Position The Medical Writer works closely with cross-functional project teams to manage preparation of the… 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
- 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
- J&J Family of Companies (Columbus, OH)
- Senior Technical Writer - 2406186355W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to ... humanity. Learn more at https://www.jnj.com/. Ethicon is recruiting for a Senior Technical Writer based anywhere in the United States. Ethicon, part of the Johnson &… 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
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