Discover new opportunities to grow your career as a Labcorp Drug Development Medical Writing Publisher.

As a Labcorp Drug Development employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance; Labcorp Drug Development has an FSP opportunity to match your area of expertise.

Labcorp Drug Development is looking to hire a Medical Writing Publisher in Poland. In this position, you will be fully dedicated to a single sponsor. This position is open for full-time candidates.

Person in this role will be responsible for Medical Writing activities such as appendices collation, peer review and QC, and publishing for designated projects and to ensure quality and compliance with Labcorp or Sponsor's SOPs, ICH GCP, and regulatory requirements.

Essential job duties:

• Assist with preparation of study related documents, e.g. Study Protocols, Clinical Study Reports, Patient Narratives etc.
• Prepare the Clinical Study Report Appendices
• Assist with the publishing of documents within the Medical Writing Department and other departments as agreed with Medical Writing Management.
• Review timelines and ensure that Medical Writers/Project Manager/Client are informed of current status.
• Assist with the review and QC process for documents within Medical Writing.
• Ensure that work is in compliance with the relevant regulatory guidelines.
• With guidance from line management and experienced staff, set priorities for preparatory tasks and ensure deadlines are maintained.
• Co-ordinate the development and communication of study start-up plans and project-specific procedures, guidelines, documents and forms, in line with relevant SOPs, ICH/GCP and local requirements (e.g. issue the appropriate Appendices Requests in a timely manner).
• Closely monitor study progress within the scope of the Medical Writing Publisher role against plan and budget, identify any significant variance and report to Medical Writer/Line Manager/Project Manager.

Requirements:

• Minimum previous experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• Prior experience as a Publisher within a Medical Writing or clinical department for national or multinational studies would be preferred
• Demonstrated ability to follow relevant ICH guidelines (including ICH-E3,ICH-E6 and eCTD guidelines) effectively and efficiently.
• Good computer literacy with working knowledge of PCs, Microsoft Windows, and proficiency with Microsoft Office and Adobe applications.
• Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English.
• Understanding and experience of archiving systems and ICH GCP.
• Good coordination skills: assembly of clinical study report appendices and documentation.
• Knowledge and understanding of publishing tools.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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