Becton Dickinson
Senior Clinical Project Manager(m/w/x)
Full-timeWith HomeofficeSenior
Karlsruhe
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THThermo Fisher Scientific
Principal Medical Writer(m/w/x)
Karlsruhe
Full-timeRemoteSenior
Nejo AI Summary
Medical and scientific document creation for life-changing therapies. Managing complex projects and guiding junior writers required. Flexible working culture, award-winning learning and development.
Requirements
- Bachelor's degree in scientific discipline or equivalent qualification
- Advanced degree preferred
- Experience providing knowledge, skills, and abilities for job (comparable to 8+ years)
- Experience managing and directing complex medical writing projects required
- Experience in pharmaceutical/CRO industry preferred
- Submissions document experience advantageous
- Experience in Neurosciences advantageous
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- Significant knowledge of document development guidelines
- In-depth knowledge in specialty areas
- Excellent data interpretation skills
- Excellent medical writing skills
- Excellent grammatical skills
- Excellent editorial skills
- Excellent proofreading skills
- Excellent project management skills
- Advanced interpersonal communication skills
- Advanced oral communication skills
- Advanced written communication skills
- Advanced presentation skills
- Excellent negotiation skills
- Excellent judgment
- High independence in decision making
- High independence in problem solving
- Ability to mentor junior staff
- Ability to lead junior staff
Tasks
- Provide high-quality medical and scientific writing
- Plan and coordinate document creation
- Deliver final drafts to internal and external clients
- Review documents for the team
- Train and guide junior team members
- Advise on document development strategy
- Comply with regulations and industry best practices
- Collaborate with internal and external clients
- Research, write, and edit clinical study reports
- Summarize data from clinical studies
- Serve as primary author for complex documents
- Write and provide input on IBs, INDs, and MAAs
- Review routine and complex documents
- Train and mentor writers and program managers
- Ensure compliance with quality processes
- Develop and review best practices and methods
- Lead process improvement initiatives
- Develop, review, and manage performance metrics
- Represent the department at project meetings
Work Experience
- 8 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Learning & Development
- Award-winning learning and development programme
Flexible Working
- Flexible working culture
- Work-life balance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific 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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THThermo Fisher Scientific
Principal Medical Writer(m/w/x)
Karlsruhe
Full-timeRemoteSenior
Nejo AI Summary
Medical and scientific document creation for life-changing therapies. Managing complex projects and guiding junior writers required. Flexible working culture, award-winning learning and development.
Requirements
- Bachelor's degree in scientific discipline or equivalent qualification
- Advanced degree preferred
- Experience providing knowledge, skills, and abilities for job (comparable to 8+ years)
- Experience managing and directing complex medical writing projects required
- Experience in pharmaceutical/CRO industry preferred
- Submissions document experience advantageous
- Experience in Neurosciences advantageous
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- Significant knowledge of document development guidelines
- In-depth knowledge in specialty areas
- Excellent data interpretation skills
- Excellent medical writing skills
- Excellent grammatical skills
- Excellent editorial skills
- Excellent proofreading skills
- Excellent project management skills
- Advanced interpersonal communication skills
- Advanced oral communication skills
- Advanced written communication skills
- Advanced presentation skills
- Excellent negotiation skills
- Excellent judgment
- High independence in decision making
- High independence in problem solving
- Ability to mentor junior staff
- Ability to lead junior staff
Tasks
- Provide high-quality medical and scientific writing
- Plan and coordinate document creation
- Deliver final drafts to internal and external clients
- Review documents for the team
- Train and guide junior team members
- Advise on document development strategy
- Comply with regulations and industry best practices
- Collaborate with internal and external clients
- Research, write, and edit clinical study reports
- Summarize data from clinical studies
- Serve as primary author for complex documents
- Write and provide input on IBs, INDs, and MAAs
- Review routine and complex documents
- Train and mentor writers and program managers
- Ensure compliance with quality processes
- Develop and review best practices and methods
- Lead process improvement initiatives
- Develop, review, and manage performance metrics
- Represent the department at project meetings
Work Experience
- 8 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Learning & Development
- Award-winning learning and development programme
Flexible Working
- Flexible working culture
- Work-life balance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Thermo Fisher Scientific
Industry
Pharmaceuticals
Description
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
Not a perfect match?
- Becton Dickinson
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MOM Proposal Consultant(m/w/x)
Full-timeWith HomeofficeExperiencedKarlsruhe - PPD Germany GmbH & Co KG
Clinical Trial Coordinator - FSP(m/w/x)
Full-timeWith HomeofficeNot specifiedKarlsruhe