Medical Writer Job at Planet Group, New Brighton, MN

QTk4b3N3YTgyTU5JdVhhVStCR3dHREhvRVE9PQ==
  • Planet Group
  • New Brighton, MN

Job Description


The Clinical Evaluation Specialist supports the development of clinical evaluation documents e.g. CEP CER PMCFP PMCFR and SSCP throughout the product development and lifecycle. Experience in medical or scientific writing critical literature review and data analysis and/or quality engineering/risk management and strong written and verbal communication skills are needed. This support role will support a lead author through the clinical evaluation process by writing documents reviewing literature and other tasks under the direction of the lead author.

Responsibilities may include the following and other duties may be assigned:
  • Supports the clinical evaluation process by writing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), Post Market Clinical Follow Up Reports (PMCFR) and Summary of Safety and Clinical Performance [SSCP] for medical devices. 
  • Identifies, evaluates, appraises, analyzes, summarizes and synthesize clinical evidence including data from sources such as preclinical studies, clinical investigations, literature, and other post-market surveillance sources. Analyzes results in preparation for product applications and submissions.  
  • Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence. Review and summarize scientific literature (e.g. screens articles against inclusion/exclusion criteria, analyzes and appraises the quality, suitability and relevance of the included studies, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports).
  • Reviews IFUs, Risk Management files and other cross-functional documents to ensure alignment of risk information.
  • Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
  • Clearly and timely communicates timelines, required inputs for projects, project risks, etc. with cross-functional stakeholders.

Required Knowledge and Experience:
  • Requires a Baccalaureate degree with minimum 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.
  • Experience in medical or scientific writing critical literature review and data analysis and/or quality engineering/risk management and strong written and verbal communication skills are needed.

Job Tags

Contract work,

Similar Jobs

Palmetto Inn & Suites

Room Attendant (Housekeeper) Job at Palmetto Inn & Suites

 ...Sea Resorts in a professional and timely manner. This includes cleaning all...  ...attention to detail and ability to work independently.* Ability to work as part of a team.* Excellent customer...  ...Hours:* Morning: 7:00am - 3:00 pm* Evening: 3:00 pm - 11:00 pm* Mid: 12:00... 

Geotech Engineering and Testing

Soils Driller Helper Job at Geotech Engineering and Testing

 ...with paperwork. You do not have to have experience in our industry. We will train you if you...  ...team member with you when you're in the field. If you feel that you are a fit...  ...a warehouse position. This is NOT an Oil Field position. Must have a valid Texas... 

Ansible Government Solutions

Compliance & Credentialing Specialist Job at Ansible Government Solutions

 ...previous experience navigating federal background investigation requirements, and particularly the requirements of the Department of Veterans Affairs. Ansible is a Service-Disabled Veteran-Owned Small Business (SDVOSB) providing Federal customers with solutions in many... 

Banfield Pet Hospital

Veterinary Assistant Job at Banfield Pet Hospital

Veterinary Assistant Careers at Banfield Pet Hospital For those who want to put their love of pets into action, there are few jobs more rewarding...  ...or the equivalent combination of education, training and experience that provides the required knowledge, skills and abilities.... 

JPMorgan Chase & Co.

Site Reliability Engineer III Job at JPMorgan Chase & Co.

 ...applying your skillsets to drive innovation and modernize the world's most complex and mission-critical systems. As a Site Reliability Engineer III at JPMorgan Chase within the Enterprise technology team, youwill solve complex and broad business problems with simple...