Medical Writer RWLP, Poland
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Medical Writer, Real World Late Phase to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
We can consider hiring this role in Ukraine, Poland, Romania, Italy, Bulgaria or Slovakia.
The successful hire will be responsible for the following:
• Writes, edits, and performs quality control (QC) reviews for CSRs, protocols, and IBs
• Assists in writing Integrated Summaries of Safety and Efficacy (ISS and ISE) and other New Drug Application (NDA) components, as well as other regulatory documents necessary for regulatory submission
• Writes and develops manuscripts and/or posters for publication
• Creates in-text tables and word processing
• Compiles document appendices, attachments, etc.
• Reviews associate medical writer generated documents and provides constructive feedback (mentoring)
• Assists in the review of draft statistical analysis plans (SAPs) prior to database lock and provides feedback to the team when appropriate
• Conducts background research as necessary for each assigned project, including literature searches
• Works on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and sponsors
• Participates in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results
• Ensures timeline adherence for each assigned project
• Facilitates a team approach for each assigned project
• Provides project status updates on a regular basis
• Carries out contractual obligations for each assigned project based on the sponsor proposal
• Maintains a working knowledge of departmental Standard Operating Procedures (SOPs) and International Conference on Harmonization (ICH) guidelines
• Serves as a core team member to review major project documents
• Exhibits professional conduct at all times • Maintains familiarity with literature search techniques • Participates in staff, departmental, and company meetings
• Adheres to required Premier Research training plan