Medical Writer I – Clinical Trial Transparency Specialist
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Job Description
Manage and facilitate anonymization of datasets and documents while collaborating with cross-functional teams at Syneos Health. Ensuring compliance with global clinical trial disclosure and transparency guidelines.
Responsibilities:
- Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements
- Work closely with Biostatistics and Programing groups and Medical Writing teams to identify and assimilate the required documents and datasets
- Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk according to GDPR guidance
- Process datasets and documents and apply required transformations
- Contribute to Anonymization Reports to support anonymization packages for policies of Health Canada and EMA
- Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications
- Quality check of documents redacted/anonymized by other team members
- Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System
- Assist in the development of internal work instructions, training materials, and procedures as needed to comply with global requirements and Incyte policies
- Ability to work with minimum supervision and resolve issues
- Develop and maintain collaborative relationships internally to ensure effective and efficient working relationships and the delivery of high quality deliverables
- Stay informed of new clinical trial disclosure and transparency requirements globally
Requirements:
- Bachelor's degree in a scientific or technical field
- Minimum 3 years of work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.)
- Working knowledge of the global regulatory guidelines pertaining to clinical trial disclosure and transparency
- Demonstrated experience in global clinical trial disclosure and transparency processes and systems
- Demonstrated Excel and analytical skills, working knowledge of SharePoint and/or document management systems
- Strong communication, organizational, time management, and project management skills
- Knowledge of ICH-GCP, awareness of clinical publication practices and standards (ie, ICMJE)
Benefits:
- We are passionate about developing our people, through career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Commitment to building an inclusive culture
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