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Senior Regulatory Affairs Medical Writer (m/f/d) (DE)
[5834]
Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort. To support our team we are looking for a Senior Regulatory Affairs Medical Writer (m/f/d) Your tasks ·Manage regulatory submission timelines and tracks documents through internal review and approval process and communicates changes or significant updates internally ·Author clear, grammatically correct, technical medical/scientific text ·Participate on project teams, internal and external discussion to keep up to date with project strategy, regulatory agency interactions and key messages ·Coordinate writing activities for document development ·Structure documents with clarity to present complex information in a logical way ·Expertly summarise data and concepts and guide the companies team through the process to effectively communicate to regulators/regulatory assessors ·Ensure that the content, format and structure of documents comply with regulatory or other guidelines ·Ensure the accuracy of all information, data and referencing for the authored documents ·Review and proofread materials to check quality and scientific accuracy ·Proactively track projects, monitor deadlines and review cycles for on-time delivery of authored documents ·Ensure compliance, remain informed on regulations and developments in medical writing ·Maintain knowledge of product areas, current trends, and current literature Your qualifications ·Post graduate degree in a life sciences discipline ·5+ years experience in regulatory medical writing ·The position is largely set in a remote environment. ·Native English speaker with an excellent command of the English language ·Proven ability to communicate clearly and precisely in various written formats and face to face ·Demonstrated ability to deliver high-quality regulatory writing ·Global regulatory (FDA/EMA) submission experience preferred ·Immunology, inflammatory disease and oncology experience preferred ·Ability to understand the analyses used in clinical trials and comfortable with statistics ·Excellent project management skills ·Excellent interpersonal skills ·Keen attention to detail ·Flexibility to move quickly between projects and work across different therapy areas ·Good working knowledge of the healthcare and pharmaceutical industry ·A positive can-do attitude ·Ability to work independently but contribute pro-actively to a project team For further questions, please contact Mr. Tilman Grumbd at +49 441 21879-34 or via e-mail at tilman.grumbd@optares.de.
- Manage regulatory submission timelines and tracks documents through internal review and approval process and communicates changes or significant updates internally
- Author clear, grammatically correct, technical medical/scientific text
- Participate on project teams, internal and external discussion to keep up to date with project strategy, regulatory agency interactions and key messages
- Coordinate writing activities for document development
- Structure documents with clarity to present complex information in a logical way
- Expertly summarise data and concepts and guide the companies team through the process to effectively communicate to regulators/regulatory assessors
- Ensure that the content, format and structure of documents comply with regulatory or other guidelines
- Ensure the accuracy of all information, data and referencing for the authored documents
- Review and proofread materials to check quality and scientific accuracy
- Proactively track projects, monitor deadlines and review cycles for on-time delivery of authored documents
- Ensure compliance, remain informed on regulations and developments in medical writing
- Maintain knowledge of product areas, current trends, and current literature
Your qualifications
- Post graduate degree in a life sciences discipline
- 5+ years experience in regulatory medical writing
- The position is largely set in a remote environment.
- Native English speaker with an excellent command of the English language
- Proven ability to communicate clearly and precisely in various written formats and face to face
- Demonstrated ability to deliver high-quality regulatory writing
- Global regulatory (FDA/EMA) submission experience preferred
- Immunology, inflammatory disease and oncology experience preferred
- Ability to understand the analyses used in clinical trials and comfortable with statistics
- Excellent project management skills
- Excellent interpersonal skills
- Keen attention to detail
- Flexibility to move quickly between projects and work across different therapy areas
- Good working knowledge of the healthcare and pharmaceutical industry
- A positive can-do attitude
- Ability to work independently but contribute pro-actively to a project team
Tilman Grumbd