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Clinical Documentation Specialist
3 weeks ago
As a seasoned regulatory writer, you will play a pivotal role in crafting high-quality clinical and safety documentation that meets the stringent requirements of regulatory authorities worldwide.
About the RoleThe ideal candidate will be responsible for authoring and reviewing complex clinical and safety documents, including non-registration Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
Key Responsibilities:
- Develop high-quality clinical and safety documents that adhere to global regulatory standards.
- Collaborate with cross-functional teams to ensure seamless document production and review.
- Maintain a thorough understanding of biostatistics principles and their application in clinical trials.
- Effectively prioritize and manage multiple projects simultaneously, ensuring timely delivery of high-quality documents.
- Contribute to the development of company policies and procedures related to medical writing and document management.
- Possess excellent communication and interpersonal skills, with the ability to work effectively in a matrix environment.
- Hold a university degree in life sciences or a related field, with advanced degrees being highly desirable.
- Bring relevant experience in medical writing or pharma industry roles, with a strong track record in producing high-quality clinical and safety documents.
- Stay up-to-date with evolving regulatory guidelines and emerging trends in the field.
What We Offer:
We are committed to fostering a culture of diversity, equity, and inclusion, where everyone feels valued and supported. Our team is dedicated to creating innovative solutions that improve patient outcomes and advance medical research.
If you are a motivated and detail-oriented individual with a passion for regulatory writing, we encourage you to apply for this exciting opportunity.
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