26 days old

Clinical Medical/Technical Writer - CER & Medical device experience

Kelly Services
Alpharetta, GA 30009
**Kelly Services** is currently seeking a **Clinical Medical/Technical Writer** in **Alpharetta, GA** to work a contract assignment 12 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities includes:**

Looking for a qualified Clinical Medical/Technical Writer to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.


Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, clinical study reports; and technical dossiers. Conducts comprehensive literature evaluations, product complaint reviews, and other product specific information to compile literature based clinical evaluation reports. Manages study team participation in the preparation of such documents, including calling/running meetings, developing timelines, and managing the document review and comment adjudication processes. Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials


Bachelors or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

EXPERIENCE Fulfills one of the following: Up to 2 years of as a medical writer in the medical device industry. At least 5 years of medical or scientific writing experience as a primary job responsibility. Medical Writing Experience writing, reviewing, or editing protocols and clinical study reports and literature based clinical evaluations highly preferred. Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content. Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals. Ability to interpret basic tabular and graphical clinical data presentations. Ability to create basic tables using AMA style (eg, Schedule of Events). Intermediate applied knowledge of basic clinical laboratory tests. Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Basic understanding of biostatistical and clinical research concepts. Regulatory Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).

Essential Duties and Responsibilities: Responsible for writing CERs according to the organizations SOP, MEDDEV 2.7/1 rev 4 (June 2016), and MDR requirements, and as directed by the senior team member. Ensure that the CERs are linked to appropriate Quality Systems and Regulatory documents (e.g., Risk Management, post-market surveillance (PMS), etc.) to make certain information is consistent and accessible where needed. Assist in the development of schedules to ensure that CER time-lines are met. Participate in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile, while continually improving process efficiencies. Support, and at times, act as a Subject Matter Expert (SME) during audits and inspections pertaining to CER processes and reports. Will actively partner with cross-functional business partners such as the Medical Director, PMS, Design Quality Engineers, R&D, and Regulatory Affairs related to the CER process.

Your qualifications Required: BA, BS, BSN, or relevant medical/allied health degree. A minimum of 3 years of related job experience. Experience within the medical device industry and knowledge of CER regulatory requirements, medical/scientific literature-based evidence generation, and CER creation/revision.


**For immediate consideration, please send your resume in a WORD document to**

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at


Posted: 2020-12-25 Expires: 2021-01-25

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Clinical Medical/Technical Writer - CER & Medical device experience

Kelly Services
Alpharetta, GA 30009

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