Medical Writer - Remote
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.
Education & Qualifications
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- 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.
- Creates writing deliverables that include, but may not be 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
- 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.
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
- Serves as peer reviewer on internal review team.
- 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.
- Performs on-line clinical literature searches, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
- Performs other work-related duties as assigned.
- Minimal travel may be required (less than 25%).
- 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.
- 5 - 7 years of experience
- 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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance