Medical Writer I

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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.