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Technical Writer - CER Lead

Kelly Services
Santa Ana, CA 92702
  • Jobs Rated
    40th
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Technical Writer** **- Clinical Evaluation Report Lead** at a prestigious Fortune 500 company working in **Santa Ana, CA.**





**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 button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: Technical Writer - Clinical Evaluation Report Lead**





Location: Santa Ana CA - 100% on site, no remote candidates please





Length of assignment: 1 year + open ended





**4 Openings**



**Pay:**



2 Sr. Level 5 yrs + exp/Pay: $100-110K annum + benefits



2 for Tech Writers 2 years+ exp/Pay$85-90K annum + benefits





**Responsibilities** :



The Technical Writer - Clinical Evaluation Report 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. 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** :




+ Responsible for the 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 JJVs 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

+ Five (5) years of related job experience in medical or scientific writing; less than 5 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 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) preferred

+ 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)







**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**



**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**










**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 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.

Categories

Jobs Rated Reports for Technical Writer

Posted: 2019-02-11 Expires: 2019-03-14

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Technical Writer - CER Lead

Kelly Services
Santa Ana, CA 92702

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