Entry-level Medical Writer

Kelly Services’ Outsourcing & Consulting Group has an opening for an Entry-level Medical Writer.  The Medical Writer will assist in the planning and execution of general medical writing activities including systematic literature reviews, Clinical Evaluation Reports (CER), Post-Market Clinical Reports (PMCRs), and other clinical research documents as needed (e.g. clinical study reports) for assigned therapeutic area and projects.  This is an open-ended, benefited assignment based in Santa Ana, CA.  Please note this is an on-site position, not remote.

 

POSITION DUTIES & RESPONSIBILITIES:

  • Prepares clinical research documents containing clinical and technical data in support of medical device product lines. 
  • Participates in the planning and execution of clinical documents for assigned therapeutic area and projects including systematic literature reviews, post-market clinical reports (PMCRs), clinical evaluation reports (CERs)/plans (CEPs), clinical study reports (CSRs), and other clinical documents as needed (e.g. new clinical documents related to the upcoming 2020 EU MDR regulations).
  • Communicates with other writers, clinical scientists, clinical study managers, engineers, project managers, regulatory associates, product safety, etc. to correctly incorporate clinical and technical content. 
  • Completes document formatting and layout. 
  • Assist literature searches (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
  • Utilize 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.)
  • Collects and compiles available clinical evidence for CER updates (clinical study outcomes, post-market surveillance data, PMCF updates, etc.), completion of post-market clinical reports (PMCRs) for product surveillance
  • Ensures maintenance of CERs/CEPs and CER/CEP updates in a document control management system (e.g. Agile).
  • Prepares/assists clinical study report generation by tracking and maintaining raw data tables/listings from biostatistics, drafting text, formatting tables, compiling final documents.
  • 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.
  • Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7/1) and electronic templates.
  • 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
  • Three (3) years of related job experience in medical or scientific writing; less than 3 years 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 preferred
  • Skilled in narrative or systematic literature reviews (e.g. PRISMA, Cochrane) preferred
  • Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is preferred 
  • Able to understand and interpret statistical results of clinical studies and understands good data management practices
  • Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines
  • Experience using software systems to manage literature data (e.g. Distiller) preferred
  • 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. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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