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Regulatory Medical Writer

Kelly Services

Santa Ana, CA 92702
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Job Details

**Regulatory Medical Writer**

Kellys Outsourcing & Consulting Group is seeking a **Regulatory Medical Writer** (Writer) in **Santa Ana, CA** . This will start as a six- month contract with likelihood of extension and includes enhanced benefits. The Writer prepares/assists with clinical research documents containing technical data in support of medical device product lines. Documents may include literature reviews, clinical evaluation reports and plans, clinical study reports. The Writer also communicates with other writers, clinical study managers, engineers, project managers, regulatory associates, product safety etc. to correctly incorporate technical content and completes document format and layout.

Core Job Responsibilities

+ Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

+ Assist with literature searches (reviewing/appraising, summarizing/analyzing clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation.

+ Collect and compile 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, maintenance of CERs/CEPs and CER/CEP updates in a document control management system.

+ Prepare/assist clinical study report generation by tracking and maintaining raw data tables/listings from biostatistics, drafting text, formatting tables, compiling final documents.

+ Incorporate text, tables, graphs, charts, statistical analyses, etc. into clinical documents in a clear and accurate manner with proper formatting.

+ Work in a team with other clinical research personnel and external medical writers for generation of clinical documents.

+ Maintain compliance with corporate policies, state, federal and international regulations.


+ Bachelor of Science (BS) required; MS or PhD degree preferred

+ At least 1 year of experience with generation of clinical evaluation reports and/or clinical research documents or 4 years of general experience in technical/medical writing. Note: Less than 1-year writing experience with advanced degree (M.S. or higher) may be acceptable.

+ Proficient/expert in Microsoft Word (version 2010 or later).

+ Ability to read/understand clinical literature (knowing where to find certain information in a scientific article to import into Distiller)

+ Knowledgebility to format Word documents including styles, tables, cut and paste text/tables without formatting errors, etc.

+ Computer/IT savvy

Qualified candidates are those seeking a medical writer career with regulatory, clinical, clinical report, and technical writing experience. Candidates may be asked to submit 1-2 writing samples prior to an interview request.

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**

**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.

**AboutKelly 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 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. at
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