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Senior Document Review Specialist
hace 2 meses
We are seeking a highly skilled Senior Document Review Specialist to join our team at Mygwork, a leading platform for the LGBTQ+ business community. As a Senior Document Review Specialist, you will play a critical role in ensuring the quality and accuracy of documents related to clinical trials, regulatory submissions, and medical writing projects.
Key Responsibilities- Review and edit highly technical documents, including regulatory submissions, integrated clinical study reports, and serious adverse event narratives, to ensure they meet or exceed client expectations.
- Verify data in tables against source documents and ensure consistency with current regulatory standards and guidelines.
- Edit documents for accuracy, consistency, and grammatical correctness.
- Adjust schedule to accommodate unexpected requests for priority review.
- Revises scientific language for usage, flow, clarity, and audience appropriateness.
- Proactively query authors to ensure compatibility with unique preferences and scientifically sound judgment.
- Maintain, communicate, and apply knowledge of current guidelines, templates, and industry standards.
- Coordinate the work of team members and track the status of documents being reviewed.
- Mentor junior team members.
- Represent the department at meetings with clients.
- Contribute to the development and modification of the quality review process.
- Collaborate with writers to manage alliance accounts.
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message.
- Thorough knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g. ICH), and requirements of the FDA and other international regulatory agencies.
- Familiarity with interpreting data and excellent analytical ability.
- Effective oral and written communication skills.
- Good organizational and planning skills.
- Good interpersonal skills.
- Ability to work on own initiative.
- Good computer literacy and expertise.
- Competent word processing skills.
- Solid understanding of document management systems.
- Suitable level of expertise within a broad range of medical writing projects.
- Good knowledge of global and regional medical writing and regulatory affairs duties for clinical trials, marketing authorization, and late-phase procedures.
- Capable of providing general advice and training to others.
- Capable of working well under pressure and remaining motivated.
- Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Mygwork is an innovative, forward-thinking organization that values diversity, equity, and inclusion. We offer outstanding career and development prospects and a dynamic work environment that fosters growth and collaboration.
