Technical Writer/Clinical Evaluation Lead - Multiple Openings!

Kelly Services’ Outsourcing & Consulting Group has multiple openings for Technical Writers/Clinical Evaluation Report Leads.  Positions can be based in Santa Ana, CA or Jacksonville, FL or be remote-based. There are openings for candidates with 2-5 years’ experience and 5+ years’ experience.  All positions are open-ended and offer benefits!

 

The Technical Writer/Clinical Evaluation Report (Tech Writer) Lead is responsible for the planning and execution of systematic literature reviews, Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEPs) and Post-Market Clinical Reports (PMCRs) for assigned therapeutic area and projects. The Tech Writer may also participate in planning/writing of other general medical writing activities including other clinical research documents as needed (e.g. clinical study reports).

 

Position Duties & Responsibilities:

  • Planning and execution of clinical documents related to EU regulatory compliance for assigned therapeutic area and projects including systematic literature reviews, clinical evaluation plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Reports (PMCRs) and other clinical documents as needed (e.g. new clinical documents related to the upcoming 2020 EU MDR regulations).
  • Collects and compiles available clinical evidence for CER updates (clinical study outcomes, post-market surveillance data, PMCF updates, etc.) and completion of post-market clinical reports (PMCRs) for product surveillance.
  • Ensures CER and CEP documents include references to the appropriate quality system and regulatory documents (e.g. risk management documents, PMS, etc.) to make certain information is consistent; manages communication with cross functional business partners to ensure appropriate information is obtained and referenced.
  • Assists in the development of schedules to ensure CER and PMCR timelines are met.
  • Ensures maintenance of CERs/CEPs and CER/CEP updates in a document control management system (e.g. Agile).
  • Leads/oversees literature search process (generating literature search protocols, reviewing/appraising results obtained, summarizing/analyzing pertinent clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation
  • Communicates with other writers, clinical scientists, clinical study managers, engineers, project managers, regulatory associates, product safety, etc. to ensure clinical and technical content appropriately incorporated.
  • Oversees/reviews document drafts from Medical Writers as appropriate; works directly with Medical Writers to ensure timely completion of clinical documents.
  • Completes document formatting and layout as necessary. 
  • Utilizes software to support the core process steps for systematic literature reviews (e.g. Distiller)
  • Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports.
  • Organizes clinical data from literature into references, graphics, tables, and data listings
  • Understands, interprets and summarizes complex results from the scientific literature including statistical results of clinical studies; presents results in a clear, concise and scientifically accurate manner for various end users (e.g. regulatory bodies, etc.)
  • Incorporates text, tables, graphs, charts, statistical analyses, etc. into clinical documents in a clear and accurate manner with proper formatting.
  • Works in a team with other clinical research personnel and external medical writers for generation of clinical documents; may oversee external vendor contractors/work.
  • Prepares other clinical research documents containing clinical and technical data in support of medical device product lines as needed (e.g. clinical study reports). 
  • Includes tracking and maintaining raw data tables/listings from biostatistics, drafting text, formatting tables, compiling final documents.
  • Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7/1) and electronic templates.
  • Supports and at times may act as an SME during audits and inspections pertaining to CER/PMCR processes and reports.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Maintains compliance with state, federal and international regulations.

 

Education & Experience Requirements:

  • BA, BS, or BSN is required; advanced degree is preferred
  • 2+ years of related job experience in medical or scientific writing for the Tech Writer; 5+ years for the Senior Level.  Less experience with advanced degree (M.S. or higher) may be acceptable
  • Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is required
  • Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, product development processes, medical device risk management processes and common biostatistical methods is preferred 
  • Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines
  • Skilled in narrative or systematic literature reviews (e.g. PRISMA, Cochrane)
  • Experience using software systems to manage literature data (e.g. Distiller)
  • Able to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence
  • Strong oral communication, presentation, project management and prioritization skills
  • Excellent interpersonal relationships
  • Highly proficient in Microsoft Office Suite (MS Word in particular) and bibliographic software (e.g. Endnote, Reference Manager)

 

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

 

This position comes with enhanced benefits which include:

  • 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
  • Paid holidays
  • Paid sick days and vacation days*

 

Perks of being a Kelly employee:

  • Weekly electronic pay
  • Access to more than 3,000 online training courses though Kelly Learning center
  • Online application system
  • Never an applicant fee

 

*benefits to be received upon meeting eligibility requirements

 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.

Why Kelly®?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services┬« workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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