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Clinical Documents Lead Writer
3 weeks ago
We are seeking an experienced Clinical Documents Lead Writer to join our team at Syneos Health. As a Clinical Documents Lead Writer, you will be responsible for developing clinical documents for submissions to regulatory authorities globally.
About the Role:
- You will oversee the medical writing activities of multiple compounds and serve as lead writer for individual summary documents.
- You will mentor and lead less experienced medical writers on complex projects, as necessary.
- You will develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, internal authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- You will lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for the assigned programs/compounds.
- You will develop good working relationships with internal and external colleagues.
- You will lead or participate in cross-functional process improvement initiatives.
Key Responsibilities:
- Develop clinical documents for submissions to regulatory authorities globally.
- Oversee the medical writing activities of multiple compounds and serve as lead writer for individual summary documents.
- Mentor and lead less experienced medical writers on complex projects, as necessary.
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, internal authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for the assigned programs/compounds.
