Medical Writer jobs in Michigan

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Medical Writer
  • SunMED Medical
  • Grand Rapids, MI FULL_TIME
  • The medical writer is primarily responsible for preparing Clinical Evaluation Reports (CERs) and associated documents for regulatory submissions and Post-market Surveillance for analysis of existing product clinical performance, while working in a cross-functional team.  This includes conducting searches of peer-reviewed publications, risk management files and post market quality tabulations to compile relevant data. Report preparation involves summarizing data and writing risk versus benefit analyses for products in a format defined to satisfy regulatory requirements. The medical writer may also prepare technical documents, study protocols, investigational plans, manuscripts for publication, or white papers. The scope includes AirLife anesthesia and respiratory medical devices.

    Principal Duties and Responsibilities:

    • Develop Clinical Development Plan as part of design validation for new medical devices to support product registrations internationally
    • Prepare Clinical Evaluation Plan (CEP) & Clinical Evaluation Report (CER) documents in accordance with European Union guidance using relevant information compiled from clinical research, peer reviewed publications, risk management files and post market data. This will also include project management of CER or Post Market Surveillance (PMS) activities in collaboration with quality and regulatory organization
    • Maintain periodic updates, perform gap analysis, and revise existing CERs to meet current international regulations
    • Collaborate with the Quality, Engineering & Regulatory Affairs organization and perform Clinical Risk Benefit Analysis (CRBAs) to support risk management activities
    • Collaborate with Regulatory Affairs and provide support to respond to clinical questions from regulatory agencies
    • For all documents, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers
    • Conduct scientific literature searches and clinical evidence mapping, manage the literature database, and prepare literature reviews for external and internal stake holders
    • Participate in the periodic reviews of recent scientific publications and online content relevant to the business, draft article summaries for distribution to key stakeholders
    • Develop and maintain SOPs and writing tools, such as templates and style manuals
    • May attend conferences to keep current with advancements in the field; contribute to the development of conference coverage reports for internal distribution
    • Develop and create clinical study protocols, protocol amendments, informed consent forms, case report forms, and study reports (e.g., human factors testing, user preference evaluations, performance bench studies.) in support of the Clinical Affairs department and in coordination with Regulatory Affairs and Engineering
    • Performs other duties and task for Clinical Affairs, as required

     Skills

    • Strong verbal, written, and interpersonal communication skills
    • Demonstrated bibliographic research and editorial skills
    • Strong organizational skills, attention to detail and proofreading skills
    • Strong ability to interpret and disseminate results of published literature and clinical studies, working knowledge of statistics
    • Basic understanding of regulatory compliance for medical device
    • Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
    • Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) 
    • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment
    • Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases
    • Project management skills

    Education/Experience Requirements:

    • BS/BA in respiratory therapy, nursing or a similar technical discipline preferred.
    • Three or more years of experience as a medical or clinical research writer, or an equivalent combination of education and experience.
    • Minimum of one-year experience of authoring Clinical Evaluation Reports to the EU MDR Regulation 2017/745.
    • Clinical background in the medical device industry desired, with a strong preference to those with experience in the respiratory and anesthesia products

    Experience:

    • 3 years of medical writing required
    • 3 years working in the medical device industry 
    • 3 years of literature search required
    • Bachelor's Degree required, Master preferred

    Travel: up to 20%

  • 10 Days Ago

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Medical Writer
  • AirLife
  • Grand Rapids, MI FULL_TIME
  • COMPANY SUMMARY At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a m...
  • 11 Days Ago

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Medical Writer
  • SunMed LLC
  • Grand Rapids, MI FULL_TIME
  • COMPANY SUMMARY At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a m...
  • 16 Days Ago

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Scientific Medical Writer
  • McLaren Health Care
  • Michigan, MI FULL_TIME
  • Position Summary: The Scientific/Medical Writer plays a critical role in the development and execution of Karmanos Cancer Institute (KCI) oncology clinical research studies. The primary responsibility...
  • 2 Days Ago

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Medical Records Analyst/Writer-Veteran's Disability
  • Disability Law Group
  • Troy, MI FULL_TIME
  • Disability Law Group exclusively specializes in helping disabled individuals get the disability benefits they deserve. Unfortunately, people go through what seems like an uphill battle to win their di...
  • 6 Days Ago

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Writer
  • Mondelēz International
  • Fenton, MI FULL_TIME
  • Description Join our Mission to Lead the Future of Snacking AT Mondelēz International Full Time Nabisco Merchandiser / Order Writer Join our team of Full Time Nabisco Merchandiser / Order Writers and ...
  • 3 Days Ago

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Medical Writer
  • Flywheel Partners
  • New York, NY
  • DESCRIPTION Training + Communications + Healthcare. We have an immediate opening for a full-time, entry-level Writer & C...
  • 3/29/2024 12:00:00 AM

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Principal Medical Writer
  • Albion Rye Associates
  • Job Title: Principal Medical Writer Location: Boston MA Position Summary: Join a dynamic team as a Principal Medical Wri...
  • 3/29/2024 12:00:00 AM

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Medical Writer
  • LanceSoft
  • Titusville, NJ
  • Title: Plain Language Summary Writer/Medical Writer/Clinical Writer Location: Titusville, NJ 08560 (Remote) Duration: 06...
  • 3/28/2024 12:00:00 AM

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Medical Writer
  • Randstad Life Sciences US
  • Title: Medical Writer Location: Remote | based in IL Pay: $50-59/hr Contract: 12+ months Summary The Senior Medical Writ...
  • 3/26/2024 12:00:00 AM

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Medical Writer
  • Ascentage Pharma
  • Rockville, MD
  • Company Summary: Ascentage Pharma is a globally focused biopharmaceutical company engaged in developing novel therapies ...
  • 3/25/2024 12:00:00 AM

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Medical Writer
  • Randstad Life Sciences US
  • Northbrook, IL
  • A major Pharmaceutical company “Contribute toward improving the health of people around the world through the provision ...
  • 3/25/2024 12:00:00 AM

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Medical Writer
  • Source One Technical Solutions
  • Source One is a consulting services company and we’re currently looking for the following individual a Technical Writer ...
  • 3/25/2024 12:00:00 AM

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Medical Writer
  • Randstad Life Sciences US
  • Waukegan, IL
  • Medical Writer III 3 Months Waukegan, IL (Onsite preferred, Open to remote) PR: $50 - $59.86/hr Job Description Prepares...
  • 3/25/2024 12:00:00 AM

Michigan consists of two peninsulas that lie between 82°30' to about 90°30' west longitude, and are separated by the Straits of Mackinac. The 45th parallel north runs through the state—marked by highway signs and the Polar-Equator Trail—along a line including Mission Point Light near Traverse City, the towns of Gaylord and Alpena in the Lower Peninsula and Menominee in the Upper Peninsula. With the exception of two small areas that are drained by the Mississippi River by way of the Wisconsin River in the Upper Peninsula and by way of the Kankakee-Illinois River in the Lower Peninsula, Michigan...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Medical Writer jobs
$88,485 to $109,260

Medical Writer
Attend on-site client meetings, listening to their needs, offering your feedback, and building a level of trust that will ensure future commitments.
April 21, 2023
Negotiates with cross-functional areas on project outcomes and deliverables to meet conflicting demands.
April 15, 2023
Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes.
January 27, 2023
Determines scope of QC review with the document author and the source documents and/or data required (in addition to utilizing any applicable checklist).
December 31, 2022
Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process to identify the necessary clinical and technical information for as
November 22, 2022
Medical Writer in Virginia Beach, VA
Functional knowledge of Biostatistics - Accurate description and presentation of clinical trial methods, statistical parameters, and medical data.
January 27, 2023
Medical Writer
Contribute to account plans, strategic publication plans and publication programs, where appropriate, by maintaining current awareness of developments in therapeutic area or discipline and the Springer Healthcare product portfolio.
May 02, 2023