Medical Writer – Contractor

This is a fully remote position, open to applicants in Poland.

📋 Description

• Develop documentation for pre-marketing and post-marketing clinical trials, medical affairs, safety data, product development, license applications, and post-marketing maintenance.

• Evaluate, review, and interpret non-clinical and clinical safety data along with other pertinent sources.

• Write and review aggregate reports, including PSURs/PBRERs, PADERs/Annual Reports/ACO/DSUR.

• Draft and review Risk Management Plans.

• Compose and evaluate Clinical Study Reports and Protocols.

• Conduct qualitative and quantitative signal assessments.

• Perform literature searches and compile relevant articles for aggregate reports.

• Manage and reconcile applicable process trackers.

• Act as a subject matter expert, providing training and mentorship to individuals.

• Generate Periodic Safety Line Listings (PSLL) from safety databases.

• Address inquiries from regulatory agencies and the Pharmacovigilance Risk Assessment Committee (PRAC).

• Support high-priority ad-hoc activities.

• Ensure client deliverables adhere to relevant regulatory standards and meet established timelines.

• Collaborate with Regulatory Affairs to report pharmacovigilance and drug safety information to regulatory bodies and healthcare providers.

• Train and mentor associates in Pharmacovigilance.

⛳️ Requirements

• At least 2 years of experience in Medical Writing.

• Degree in Life Science/Pharma or an equivalent qualification.

• Strong computer skills along with proficient keyboarding abilities.

• Proficient in Microsoft Office Suite (Outlook, Word, Excel).

• Excellent verbal, written, and interpersonal communication abilities.

• Strong organizational and prioritization skills; capable of multitasking.

• Flexibility to adapt to changing business priorities.

• Willingness to occasionally work extended and/or flexible hours to meet client needs.

• Ability to build relationships, collaborate, and influence across various disciplines within Sitero as well as with external stakeholders.

• Outstanding verbal, written, and presentation skills.

• Innovative, collaborative, and proactive in taking initiatives.

🏝️ Benefits

• Hourly rate aligned with the level of Drug Safety medical writing experience.

• Contract, as-needed agreement, which will be extended as a Scope of Work consulting document.