Medical Writer I - Clinical Trial Transparency Specialist - Poland (Sponsor-dedicated)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Summary of the Essential Functions of the Job

• 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.
• 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.

Minimum 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).

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.