Senior Medical Writer (Regulatory) - Multi-Sponsor
New
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Thermo Fisher ScientificClinical Research
Remote, SpainFull-TimeSenior
SalaryCompetitive remuneration, annual incentive plan bonus
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Job Details
- Experience
- 5+ years
- Required Skills
- Project ManagementMicrosoft Excel
Requirements
- Bachelor's degree in a scientific discipline or equivalent.
- Advanced degree preferred.
- Comparable to 5+ years of relevant experience.
- Experience in the pharmaceutical or CRO industry preferred.
- Additional medical writing qualifications (AMWA, EMWA, RAC) are advantageous.
- Excellent data interpretation, grammatical, editorial, and proofreading skills.
- Strong project management, problem-solving, and negotiation skills.
- Significant knowledge of global and regional document development guidelines.
- In-depth knowledge in a specialty area such as preclinical, therapeutic, or regulatory submissions.
- Proficiency with client templates, document management systems, Excel, and Outlook.
Responsibilities
- Serve as primary author for routine documents including clinical study reports and study protocols.
- Summarize data from clinical studies and contribute to complex documents such as IBs, INDs, and MAAs.
- Review routine documents prepared by junior team members and provide mentorship on document development.
- Ensure compliance with quality processes and regulatory requirements for all assigned documentation.
- Develop best practices and methods to achieve optimal results for various client-specific processes.
- Assist in program management by identifying out-of-scope activities and developing timelines and budgets.
- Represent the department at project launch, review, and team meetings.
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