Clinical Medical/Technical Writer IV (6611311)

Employment Type

: Full-Time

Industry

: Healthcare - Allied Health



SELECT SOURCE INTERNATIONAL Select Source International (SSI) has been serving major corporations for more than 15 years. At SSI, we believe in building a corporation with only the strongest and most capable individuals. Our world-class consultants have the expertise to meet our clients demands. Here at SSI, we pride ourselves on the fundamental belief that our team is essential to our companys growth. We assist our consultants every step of the way in order to match them to the best possible position for their skills.Job Title: - Clinical /Medical/ Technical writer IV (remote)Location: - 1043 - 0001 Georgia Admin Stf-Avent 5405 Windward Parkway Alpharetta GA 30004Duration: - 24+ Months (Extension possible)JOB RESPONSIBILIIES:Looking for someone that has experience in: -Clinical Evaluation Reports -CER -European regulatory authorities -Post-market surveillance -MEDDEV 2.7.1 rev 4 -Regulatory Literature Reviews This assignment will most likely last a minimum of 2 years Can work remotely, but wants someone close to the local Georgia areaLooking 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.RESPONSIBILITIES 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 materialsEDUCATION 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.Best Regards,
Sudha
Technical Recruiter
6311 Wayzata Blvd; Suite 150, Minneapolis, Minnesota 55416
(Work: 952-546-3300 Ext: 6017
email(at)selectsourceintl(dot)comDisclaimer: Select Source International (SSI) does not tolerate discrimination against any applicant on the basis of gender, sexual orientation, race, religion, national origin, ethnicity, veteran status, disability, age, sexual preference or any other protected status designated by federal, state or local law. It is SSIs policy to affirmatively recruit, hire, train, assign, transfer, evaluate, compensate, provide benefits, promote, demote, layoff, recall, and terminate employees on their own abilities, achievements and experiences. This policy applies to all SSI employee activities. SSI encourages diversity in hiring, recognizing that this enriches the work environment for all SSI associates and that a broad variety of perspectives enhances decision-making and creativity.

SSI is an Equal Opportunity Employer. If you require accessibility assistance applying for any of our positions, please send an email with your request to sudhak@selectsourceintl.com

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