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Regulatory Document Specialist
Il y a 2 mois
Job Summary
The Senior Medical Content Developer will be responsible for the creation of high-quality, English-language medical writing deliverables, ensuring timely and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will involve leading the development of regulatory and other scientific documentation, managing the collection of content from cross-functional teams, mentoring junior writers, and overseeing vendor writer activities.
Key Responsibilities:
- Coordinate medical writing activities and deliverables across multiple projects
- Work cross-functionally to write clinical and regulatory documents in support of regulatory submissions, accurately and consistently presenting key clinical messages in accordance with program goals, regulatory requirements, standards, and guidelines
- Serve as the main medical writing contact on study teams, coordinating the efforts of cross-functional teams for document development
- Detailed scheduling and management of cross-functional team deliverables impacting document delivery at the program level
- Mentor and manage the work of more junior writers
- Manage the work and deliverables of contract/vendor writers
Requirements:
- Medical studies
- Good knowledge of clinical trials environment
- Good communication skills
- English required
About Ividata Life Sciences
Ividata Life Sciences is a leading provider of medical writing services, dedicated to delivering high-quality, regulatory-compliant documents to the pharmaceutical and biotechnology industries. As a Senior Medical Content Developer, you will be part of a dynamic team that is passionate about creating innovative solutions for our clients.
