Provides scientific / regulatory guidance and technical expertise in the writing, production, and review of regulatory and other scientific / clinical documents.
Serves as medical writer on clinical study. Plans and coordinates report-writing activities with dependent staff roles to ensure satisfactory completion of all writing projects, as well as mentors and leads less experienced medical writers on complex projects
Job responsibilities :
Compiles, writes, and edits medical writing deliverables
Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas, in specific study synopsis, study protocol, abstracts, poster and manuscripts.
Advises study teams on data presentation and production strategies and on data interpretation as needed.
Interacts with cross-functional team, data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Reviews statistical analysis plans and table / figure / listing specifications for appropriate content, and for grammar, format, and consistency.
Serves as peer reviewer on internal review team.
Established regulatory standards, including but not limited to ICH-E6 guidelines, as well as company SOPs, approved templates when completing medical writing projects, on-time and on-budget.
Performs on-line clinical literature searches, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
Mentors and leads less experienced medical writers on complex projects, as necessary.
Background in a scientific or medical discipline.
At least, 1.5 years of experience as a Medical Writer in Clinical Research
Extensive knowledge of English grammar with a familiarity with a standard style guide
Ability to communicate scientific or medical information in a clear and concise manner
Familiarity with the principles of clinical research
Ability to interpret and present clinical data
Advanced degree within the field
Understanding of multiple aspects within Study Management