<b>Please note: This is a home based position - the successful candidate can be based anywhere in the US.</b><br/><br/><b>Summary: </b><br/><br/>Serves as a senior medical writer on clinical study or regulatory project teams. 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.<br/><br/><b>Essential Functions:</b><br/><br/>1. Mentors and leads less experienced medical writers on complex projects, as necessary.<br/><br/>2. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on inter-department and intra-department project teams with minimal supervision. Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas.<br/><br/>3. Creates writing deliverables that include, but may not be limited to:<br/><br/>- clinical study protocols and clinical protocol amendments;<br/><br/>- clinical study reports;<br/><br/>- clinical development plans;<br/><br/>- IND submissions and annual reports;<br/><br/>- Integrated summary reports;<br/><br/>- NDA and (e)CTD submissions;<br/><br/>- investigator brochures, as well as;<br/><br/>- clinical journal manuscripts, clinical journal abstracts, and client presentations.<br/><br/>4. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.<br/><br/>5. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.<br/><br/>6. Serves as peer reviewer on internal review team.<br/><br/>7. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.<br/><br/>8. Performs on-line clinical literature searches, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.<br/><br/><b>Other Responsibilities: </b><br/><br/>Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). <br/><br/><b>Requirements:</b><br/><br/>BA/BS degree in life sciences, clinical sciences, English/journalism, or equivalent related experience. Extensive progressive experience in medical and/or scientific writing or equivalent education and experience. Advanced degree preferred. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership 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. <br/><br/><b>Disclaimer:</b><br/><br/>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.<br/>