US National – Telecommute
Principal Medical Writer – (19008789)
The Principal Medical Writer will prepare, review and edit key documents for regulatory submission or for publication/presentationt providing technical leadership or support to other writers, ensuring that clinical data is presented in documents in compliance with applicable regulatory guidelines.
Develop a variety of documents related to regulatory, submissions, abstracts, posters, publications, presentations, medical information letters, records, press releases, brochures, and etc.
Apply appropriate scientific criteria to ensure that client objectives are met and quality standards are maintained.
Comply with client or company procedures for completing deliverables, obtaining reviews, incorporating edits, and working with teams to complete and finalize deliverables.
Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments.
Keep management and team members informed of project status and actively fead team meetings.
Review and edit documents to give maximum clarity of meaning, accuracy relevance, and consistency of style and format to ensure that client objectives are met and overall quality standards are maintained.
Continue professional development to keep pace with regulatory guidance and client expectations.
Stay aware of the budget and timeline specifications for all assigned projects, working within the budgeted hours and communicating any changes to specifications to the manager or other medical writing leaders as appropriate.
Complete all administrative tasks within specified timeframes.
Develop good working relationships with internal and external colleagues.
Interact with clients regarding project expectations and performance.
Participate in presentations to clients as requested.
Support business development activities.
Lead and support special projects as requested
Bachelor’s of Science, with relevant writing experience, or Bachelor’s degree in English or communications, with relevant science experience.
MS, MPH, PharmD, PhD, or other advanced degree is strongly preferred.
Minimum eight years relevant experience in scientific, technical or medical writing
Proven track record of scientific writing along with a strong scientific background
Strong client management, project management and team leadership skills
Previous experience in a CRO environment (preferred)
Previous exposure to proposal development and financial management (preferred)
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Primary Location North America – US Home-Based
Job Medical Affairs
Employee Status Regular
Medical & Health , Science , Writing , Technical Writing , Medical Research