Job Description

If you are an experienced Medical Writer who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Medical Writer to join our Medical and Drug Safety team. Reporting to the Senior Clinical Research Physician, this position will be remote.

This will be a defined, term full-time contract position for 6 mos. Ideal start date of late March 2023.

Responsibilities:

• Prepares, edits, collaborates, and finalizes key trial-related documents, including but not limited to: Case and Patient Narratives, Clinical Trial Protocols and Synopses, Clinical Study Reports, Development Safety Update Reports, articles for publication
• Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Completes documents according to agreed-upon timelines and follows up with both internal and external stakeholders as needed to meet timelines
• Ensures that deliverables conform to International Conference on Harmonization (ICH) or other relevant regulatory guidelines, applicable standard operating procedures (SOPs), Sponsor requirements, etc., as applicable
• Creates and maintains SOP\'s and work instructions for preparation and maintenance of compliance medical writing deliverables
• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings
• Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
• Generates/reviews specifications for generating patient narratives
• Collaborates in the analysis and interpretation of trial results and ensures results and interpretation are accurately and clearly reflected in relevant documents
• Performs bibliography searches, as requested.
• Submits abstracts, oral presentations, manuscripts etc... to the corresponding conference or journal.
• Maintains familiarity with current industry/academic practices and regulatory requirements and guidelines that affect medical writing
• Contributes with ideas/projects for new abstracts and articles.

Qualifications:

• Minimum Bachelor\'s degree in the medical-related field or life science (Post-graduate degree preferred)
• 5 years experience as a Medical Writer, writing clinical trial-related documents (experience in oncology trials strongly preferred)
• Ability to write clear, grammatically and technically correct, and creative medical/scientific text for a variety of audiences
• Broad experience managing the medical writing responsibilities associated with multiple trials at various stages
• Must have a thorough knowledge of clinical research concepts, practices and ICH (and other relevant) guidelines regarding drug development phases, clinical research, and medical writing standards with a demonstrated ability to interpret and apply these guidelines to document writing
• Knowledge of statistical principles and methods applied to clinical trials
• Ability to work independently with minimal supervision, work effectively under pressure, adapt to change as needed, possess excellent project management skills, and attention to detail
• Ability to effectively communicate with internal and external stakeholders to establish and maintain professional and productive working relationships, gain alignment on expectations, communicate progress, and escalate complex issues appropriately
• Excellent interpersonal, active listening, and influencing skills
• Proficiency in Microsoft Office suite and reference manager application
• Highly proficient in English

What TRIO Can Offer You:

• Competitive salary
• 3 weeks of vacation
• 2 weeks paid personal/sick time
• Flexible working hours
• Monthly internet allowance

Health & Safety:

TRIO is committed to creating a safe and healthy environment for everyone. As part of this commitment, TRIO has implemented a COVID 19-Vaccination Policy. Employees must be fully vaccinated against COVID-19 and provide proof of vaccination. Employees who cannot be fully vaccinated on the basis of a protected legal ground (e.g. medical) may request an exemption. Please note that this policy applies to all employees, including new hires, and contractors. If your application is successful, you will be asked to provide proof of vaccination or request an exemption.

All interviews are currently being conducted virtually - via phone or video. We thank all candidates for their interest; only those selected for an interview will be contacted.

Integrity \xe2\x80\xa2 Teamwork \xe2\x80\xa2 Passion

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Translational Research in Oncology