Sr.Mgr Medical Writing
Westlake Village, CA
Req ID 50273BR
Business Title
Sr.Mgr, Medical Writing
Business
BioScience
Sub-Business
Research and Development
Country
US
State/Province
California
Location of Position
Westlake Village, CA
Shift_
1st
Job Description
The position will be responsible for maintaining BioScience Global R&D and MA's compliance with US, EU, and other countries' laws and regulations governing the public disclosure of both clinical trial protocol information and results. The position will be responsible for interpreting and summarizing information and results from study protocols, clinical study reports, investigator agreements, and other clinical documents for incorporation into applicable public registries (e.g. in US: clinicaltrials.gov and in EU: EudraCT/clinicaltrialsregister.eu). The position will negotiate and interface within Global Clinical Development, across BioScience departments (e.g. Clinical Research and Medical Affairs within Global R&D, Marketing), and across Baxter (eg Regulatory, Legal).
Job Requirements
Must demonstrate:
• Project management and leadership skills
• Expertise in the evaluating and summarizing data
• Exceptional organizational skills and meticulous attention to detail
• Exceptional communication skills
• Interpret and apply global regulatory authorities regulations and/or guidance
• Manage multiple projects with competing priorities
• Work in a team environment
This person should also possess knowledge of writing-related computer software and electronic document management systems
Must have an academic science or clinical degree with direct experience in evaluating and summarizing data (eg, medical writing), in management/project management, and with extensive knowledge of drug development process (at least 5-7 years). Advanced degree preferred.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
