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Provides scientific writing, regulatory guidance and technical expertise in the writing, production, and review of high quality regulatory and other scientific/clinical documents ensuring that clinical data is presented in documents in compliance with applicable regulatory guidelines.
JOB RESPONSIBILITIES
? Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
? Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
? Develops good working relationships with internal and external colleagues.
? Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
? Develops or supports a variety of documents that include but not limited to:
o Clinical study protocols and clinical protocol amendments;
o Clinical study reports;
o Patient narratives;
o Clinical development plans;
o IND submissions and annual reports;
o Integrated summary reports;
o NDA and (e)CTD submissions;
o Investigator brochures, as well as;
o Clinical journal manuscripts, clinical journal abstracts, and client presentations.
? Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
? Serves as peer reviewer providing review comments to give maximum clarity of meaning,
accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.
? Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget.
? Performs on-line clinical literature searches, as applicable.
? Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
? Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
? Completes required administrated tasks within the specified timeframes.
? Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
QUALIFICATION REQUIREMENTS
? Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
? Extensive knowledge of English grammar with a familiarity with AMA style guide.
? Understanding of FDA and ICH regulations and guidelines strongly preferred.
? Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team-oriented approach.
? Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
? Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.