Associate Director, GHEOR Patient-Reported Outcomes Assessment, Cell Therapy
Bristol Myers Squibb
Principal Medical Writer
Abbott
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $97,300 - $194,700 per year
Job Level
Lead
About the role
- Manage all project tasks for the department’s most complicated, urgent, high visibility, or challenging projects; lead CFT meetings to drive to resolution and project task completion.
- Propose and implement process improvements, including writing process improvement charters, identifying CFT members, obtaining stakeholder agreement, presenting recommendations to upper management, and executing steps to implement.
- Train team members on guides, templates, checklists and/or job tools, good writing practices and Medical Writing norms. Develop and maintain training strategy for team members and ensure team members are trained.
- Maintain the guides used to create instructions for use documents and associated DIV form used to document source documents used in labeling creation; implement current regulatory feedback, ensure guide is correct/accurate and reflects most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Participate on and present changes to Labeling Process Community.
- Maintain the best practice document and chapter templates used for outside-of-US submission document creation. Implement current regulatory feedback from country affiliate managers, ensure best practice is correct/accurate and reflects most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Participate on and present changes to IRIS Process Community.
- Maintain templates and checklists used for US submission document creation. Implement current regulatory feedback, ensure templates are correct/accurate and reflect most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Present changes to users. Stay up-to-date on eSTAR versions and assess new versions for impact on templates and checklists.
- Maintain study record templates and user guides for study record creation. Implement current regulatory feedback, ensure templates and user guides are correct/accurate and reflect most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Create new templates/user guides as new study designs are created. Present changes to users.
- Maintain troubleshooting guide templates. Implement global service and support feedback. Present changes to users.
Requirements
- PHD, Masters or MD in Lifesciences or Engineering
- Strong communication skills both written and verbal
- 3-5+ years of relevant experience
- Experience on the Clinical side of Med Device
