Job Description - Principal Medical Writer - Early Phase (21001015)
Principal Medical Writer - Early Phase-(21001015)
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.
•Mentors and leads less experienced medical writers on complex projects, as necessary.
•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:
-Clinical study protocols and clinical protocol amendments;
-Clinical study reports;
-Clinical development plans;
-IND submissions and annual reports;
-Integrated summary reports;
-NDA and (e)CTD submissions;
-Investigator brochures, as well as;
-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%).
•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.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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