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Deerfield, IL 60015
Client Position Title: Medical Writer/ China CER Specialist
Position Number: 333615
Location: Deerfield, IL 60015
Position Type: Long Term Contract
Required Skill Set:
Microsoft Office, Product Management, SharePoint
Position Description:C2C is not available
Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.
Job Title: Medical Writer/China CER Specialist
Requirement Number: 9521
Start Date: 02/17/2020
End Date: 02/15/2021
Location: Deerfield IL, 60015 (Possibly Remote)
Title: China CER/PRER Specialist
The China CER/PRER Specialist supports the Global Patient Safety (GPS) team by providing expertise in the development of Clinical Evaluation Reports (CER) and Periodic Risk Evaluation Reports (PRER) for China.
The China CER/PRER Specialist provides guidance/direction to the medical writing team as to required analyses and documentation to comply with current China regulations.
Essential Duties and Responsibilities:
• Leading the development of internal processes and templates for China CERs/PRERs to ensure regulatory compliance
o Includes identifying and documenting interdependencies/responsibilities between Baxter Global functions and Baxter China functions
o Includes providing revisions if required to address feedback from the National Medical Products Administration (NMPA)
• Once processes and templates are created, responsible for developing a medical writing curriculum for China CERs and PRERs to be used for training new medical writers
o Includes development of Global Guidances (GG) which outline the required steps/process flow to complete the China CERs/PRERs
• Using the developed curriculum to provide Training sessions to new medical writers
• Developing a process for evaluating medical writing competency
• Providing CER/PRER subject matter expertise as needed by Baxter teams during development of new CERs/PRERs and remediation of existing CERs/PRERs.
• Developing schedules for China CERs/PRERs to ensure timelines are met and key contacts identified.
• Facilitating communication between the Medical Device Writing Team (MDWT) and Subject Matter Experts (SMEs) to ensure on-time delivery of high-quality regulatory documents
• Monitoring China work deliverables to ensures identification and communication of risks, and proactive management of risk response strategies escalating issues that may impede deliverable timelines.
• Maintaining knowledge of current China CER/PRER regulations and best practices for document development and maintenance
• A minimum of a Bachelor’’s degree, required
• A minimum of 5 years of experience writing China CERs, required.
• Experience writing China PRERs, preferred
• Experience developing China CER training curriculums for medical writers, required.
• Experience developing China PRER training curriculums for medical writers, preferred.
• Project management experience strongly preferred
• Excellent leadership skills to:
o respond to new demands and challenges while working effectively in ambiguous situations
o work in a multicultural and cross-functional environment to facilitate discussion and resolution of different views
• Strong writing, analytic and problem-solving skills required.
• Self-motivated with exceptional follow through.
• Strong organizational skills and meticulous attention to detail.
• Ability to apply global regulatory authorities’ regulations and/or guidance.
• Excellent English written and oral communication skills and adult-education teaching skills
• Proficient in Excel, Word, Outlook, PowerPoint, & SharePoint
• Ability to work outside the standard 8 AM-5 PM work hours, when needed, to attend WebEx/t-con meetings with global colleagues
• Ability to accommodate limited travel outside the US to provide training sessions
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)