Medical Writer I
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Job Description
Clinical Trial Transparency Anonymization Specialist managing clinical trial document anonymization at Syneos Health. Partnering with teams to ensure compliance with transparency regulations and public disclosure requirements.
Responsibilities:
- Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements.
- Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI.
- 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.
- Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents.
- 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, including but not limited to clinical trial registration and posting of results.
Requirements:
- Bachelor 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.
- We are committed to building an inclusive culture – where you can authentically be yourself.
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