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Medical Writing Coordinator

Techlink Systems

2001 Wallace Ave

North Chicago, IL 60064

Job Description

Job Title: Medical Writing Coordinator:

Description:

The Medical Writing Coordinator is responsible for providing regulatory document support to the medical writing teams, ensuring successful preparation of high quality submission-ready documents. Provides expertise in the management and coordination of casebooks and other CSR Appendix 16 documents ensuring timely completion, completeness, and formatting accuracy. Assists in the compilation of literature references and ensures delivery into the electronic submission system. May participates in process improvement activities.

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

* Develops strong knowledge of casebook and CSR appendices organization and content.

Coordinates, tracks completion, and manages acceptance of casebooks and CSR appendix documents. Manages eDOC tracking spreadsheet.

* Prepares documents for submission to RIC, Data Management, and Regulatory Affairs. Manages process, confirms completeness, and performs electronic review/QC of

casebooks and CSR appendices. Manages workflows for review/approval in eSubmission system.

* Communicates deliverables, electronic document process, and durations associated with these activities to the Medical Writing Manager,

Clinical Project Management, and other functional areas such as Publishing, RIC, etc., as required.

* Acts as interface to resolve issues associated with casebooks and CSR appendices through ongoing communication with the clinical team.

* Compiles and organizes literature references for regulatory documents. Performs literature searches.

* Ensures all electronic document deliverables are processed and compiled in alignment with timelines.

* Participates in process improvement activities.

Education:

* Bachelor of Arts or Bachelor of Science or Associates Degree preferred; equivalent experience considered.

Company Description

TechLink Systems is a privately held IT Consulting Firm that provides Consulting Services to organizations nationwide. TechLink Systems is a certified MWOBE and has been in business since 1998. Our network spans all major U.S. metropolitan areas touched by major sectors such as entertainment and leisure, finance, industry and government, health sciences, and information technology. Whether you are a client seeking IT services and support or a candidate searching for new opportunities, TechLink System's outstanding customer service and dedication will exceed your expectations in the marketplace! TechLink has 4 regional offices located in San Francisco, Los Angeles, New York City, Philadelphia and a Development Center in Bangalore, India.



Awards:
-Ranked Top 500 Asian-Owned & Asian Pacific American-Owned Businesses in the US -Ranked Top 100 Diversity-Owned & Privately-Owned Businesses in California -Ranked INC500 Fastest Growing Private Companies -Ranked Top 100 Largest Women Owned Business San Francisco Business Times -Ranked 50 Largest Minority-Owned Companies San Francisco Business Times - Ranked in Top 100 Woman Owned Business in the US, Diversity Business -Ranked in the Top 10 Minority-Owned Businesses in the Philadelphia Business Journal -Ranked in the Top 50 Woman-Owned Businesses in the 2014 Philadelphia Business Journal