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17 days old

Specialist Reg Operations - Medical Writing

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking a Specialist Reg Operations Associate - Medical Writing in Gaithersburg, MD to work a contract assignment of 5 months 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 of the** Specialist Reg Operations Associate - Medical Writing **includes:**



Operations Associate in Medical Writing Operations, Medical Communications Department



Top Three Skills:

- Familiar with Clinical study reports, CSR production (in a Pharma setting)

- Trained to format documents, PDF checks, Adobe

- Helpful to have Trial master Filing (TMF)



Main Duties and Responsibilities:




+ As Operations Associate, you will be part of Medical Writing Operations (MW Ops) and responsible for providing overall operational support in development, approval, and filing of clinical documents for regulatory submissions within the Medical Communications (MC) Department.

+ You will work under general supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.

+ Collaborate with Medical Writer on Clinical Study Report (CSR) production, including Section 14 and Appendix 16 document collection. Manage assembly and uploading to the electronic document management system (EDMS) and pre-publish CSR as per Medical Writing/MW Ops process.

+ Perform PDF checks for Adobe Acrobat documents to meet submission-ready standards for global Health Authorities.

+ Review and format diverse scope of documents in new House Style, MS Word, and perform document cleaning activities to meet submission-ready standards for global Health Authorities.

+ Assist colleagues in document formatting troubleshooting for a diverse scope of documents in MS Word and Adobe Acrobat applications.

+ Provide support with filing and QC of Trial Master File (TMF) and electronic TMF (eTMF)



Essential Requirements:




+ Knowledge of regulatory documentation, including CSR production and pre-publishing; formatting and PDF checks; and/or filing to TMF/eTMF, a plus.

+ Proficiency in MS Office 2010 and Adobe Acrobat Professional

+ Knowledge of ISIToolbox applications, and working in EDMS environment, a plus.



Desirable Requirements:




+ General understanding of the drug development process, clinical regulatory document types, the principles of GXP and ICH guidelines, and applicable standards.

+ Ability to identify and solve the problems.

+ Ability to manage and prioritize multiple projects under general supervision and work in a fast-paced environment.

+ High attention to detail.

+ Strong English written, verbal, and interpersonal communication skills.

+ Ability to work well individually as well as in a team environment.



**Education and Experience Requirement of the** Specialist Reg Operations Associate **-** Medical Writing **includes** :




+ BA/BS degree or equivalent work experience in medical writing or regulatory submission field for pharmaceutical industry, academic institutions, and/or clinical research organizations.



**Additional Information:**




+ Contract assignment, duration 5 months.

+ Work schedule: full-time, first shift.



**Kelly Temporary Employee Perks:**




+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:



Sandy at: Sanm174@KellyServices.com (reference BH Job #1644890)



Thank you for your interest in the assignment.






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding 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 90 of the Fortune 100 companies and found opportunities for more than 10,000 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.




**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 https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-11-20 Expires: 2019-12-21

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Specialist Reg Operations - Medical Writing

Kelly Services
Gaithersburg, MD 20898

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