Sobi
Global Director Medical Affairs(m/w/x)
Full-timeRemoteManagement
Basel
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Strategic authoring of clinical and regulatory documents for rare disease therapies. 8-10 years regulatory medical writing experience leading global projects required. Professional conference attendance.
Requirements
- Life Science Master's degree or PhD
- 8-10 years' experience in regulatory medical writing
- Scientific and regulatory knowledge
- In-depth knowledge of regulatory medical writing processes
- Experience leading complex global regulatory/clinical writing projects
- Experience leading writing activities for major US/EMA regulatory submissions
- Coordination of Medical Writers and submission leadership
- Clear understanding of clinical development (phases, processes, techniques)
- Advanced knowledge of global regulatory environment/processes
- Excellent written and spoken English skills
- Highly developed analytical and strategic thinking
- Ability to identify key issues
- Clear and effective communication of complex ideas
- Strong interpersonal, communication, and influencing skills
- Ability to coordinate work of others
- Strong team player
- Ability to drive and manage team performance
- Effective collaboration with diverse backgrounds
- Result-orientation
- Excellent problem-solving skills
- Flexible attitude
- Ability to manage multiple parallel tasks
- Task prioritization under time pressure
- Highly developed respect for timelines
- Attention to detail
Tasks
- Provide communication expertise for clinical programs
- Lead strategic authoring of key clinical and regulatory documents
- Ensure clarity and consistency of clinical information
- Facilitate regulatory assessment processes
- Achieve commercially viable product labels
- Direct strategy for clinical regulatory submission components
- Ensure clear and compelling scientific content
- Align content with regulatory document objectives
- Prepare key clinical and regulatory documents
- Prepare documents for major regulatory submissions
- Prepare responses to regulatory agencies
- Provide leadership to cross-functional authoring teams
- Coordinate cross-functional authoring teams
- Ensure efficient delivery of clinical regulatory documents
- Ensure high quality of clinical regulatory documents
- Ensure regulatory compliance of clinical documents
- Liaise with senior project staff
- Develop storyboards for submissions
- Plan document development for prescribing information
- Provide strategic medical writing expertise
- Support multiple clinical development projects
- Ensure high technical quality of documents
- Ensure compliance with in-house technical requirements
- Coach less experienced Medical Writers
- Develop less experienced Medical Writers
- Oversee Medical Writers on your documents
- Coordinate Medical Writers on your documents
Work Experience
- 8 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
More Vacation Days
- Generous time off
Learning & Development
- Opportunity to attend conferences
Family Support
- Work/life balance
Informal Culture
- Collaborative and team-oriented environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Strategic authoring of clinical and regulatory documents for rare disease therapies. 8-10 years regulatory medical writing experience leading global projects required. Professional conference attendance.
Requirements
- Life Science Master's degree or PhD
- 8-10 years' experience in regulatory medical writing
- Scientific and regulatory knowledge
- In-depth knowledge of regulatory medical writing processes
- Experience leading complex global regulatory/clinical writing projects
- Experience leading writing activities for major US/EMA regulatory submissions
- Coordination of Medical Writers and submission leadership
- Clear understanding of clinical development (phases, processes, techniques)
- Advanced knowledge of global regulatory environment/processes
- Excellent written and spoken English skills
- Highly developed analytical and strategic thinking
- Ability to identify key issues
- Clear and effective communication of complex ideas
- Strong interpersonal, communication, and influencing skills
- Ability to coordinate work of others
- Strong team player
- Ability to drive and manage team performance
- Effective collaboration with diverse backgrounds
- Result-orientation
- Excellent problem-solving skills
- Flexible attitude
- Ability to manage multiple parallel tasks
- Task prioritization under time pressure
- Highly developed respect for timelines
- Attention to detail
Tasks
- Provide communication expertise for clinical programs
- Lead strategic authoring of key clinical and regulatory documents
- Ensure clarity and consistency of clinical information
- Facilitate regulatory assessment processes
- Achieve commercially viable product labels
- Direct strategy for clinical regulatory submission components
- Ensure clear and compelling scientific content
- Align content with regulatory document objectives
- Prepare key clinical and regulatory documents
- Prepare documents for major regulatory submissions
- Prepare responses to regulatory agencies
- Provide leadership to cross-functional authoring teams
- Coordinate cross-functional authoring teams
- Ensure efficient delivery of clinical regulatory documents
- Ensure high quality of clinical regulatory documents
- Ensure regulatory compliance of clinical documents
- Liaise with senior project staff
- Develop storyboards for submissions
- Plan document development for prescribing information
- Provide strategic medical writing expertise
- Support multiple clinical development projects
- Ensure high technical quality of documents
- Ensure compliance with in-house technical requirements
- Coach less experienced Medical Writers
- Develop less experienced Medical Writers
- Oversee Medical Writers on your documents
- Coordinate Medical Writers on your documents
Work Experience
- 8 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
More Vacation Days
- Generous time off
Learning & Development
- Opportunity to attend conferences
Family Support
- Work/life balance
Informal Culture
- Collaborative and team-oriented environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Sobi
Industry
Pharmaceuticals
Description
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
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