Medical Writer

As a Medical Writer at SidekickHealth, you will collaborate with other team members within the Medical and Research Department to prepare high-quality protocols, grant proposals, clinical publications, and related clinical documents within agreed-upon timelines.

Responsibilities:

• Prepare, edit, and finalize protocols, and related clinical documents, such as abstracts, posters, presentations, and manuscripts
• Participate in scientific publication planning
• Review tables, figures, and listings, and narrative planning for relevant documents
• Work closely with the study teams to ensure that results and messages in clinical documents are accurately reflected
• Schedule and conduct document-related meetings, including preparing pre-meeting agendas, key data points for discussion, and post-meeting minutes
• Collaborate with clinicians, clinical scientists, and other team members to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
• Manage document review processes, ensuring conflicting and/or ambiguous comments are revised, clarified, and appropriately addressed
• Work closely with study teams to reach consensus on timelines for deliverables
• Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments
• Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
• Ensures documents are generated in accordance with agreed internal processes and standards, are submission-ready, and are appropriately stored in the agreed document management system
• Ensures that appropriate quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
• Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity

Qualifications:

• At a minimum, a Bachelor’s degree or equivalent in a medical-related field or life science
• Post-graduate degree preferred
• Bachelor’s degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
• Experience in interacting with cross-functional study team members
• Must have a thorough knowledge of clinical research concepts, practices, and medical writing standards
• Demonstrated ability to interpret and apply guidelines to document writing
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
• Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Read, write and speak fluent English; excellent verbal and written communication skills