Principal Medical Writer
The Principal Medical Writing Scientist is responsible for preparing complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. The Principal
Medical Writing Scientist is recognized as a scientific contributor and subject matter expert for clinical regulatory documentation. Works independently.
• Prepare complex clinical regulatory documents, including clinical study protocols, clinical study reports, and investigator’s brochures and sections of regulatory submissions
• Serve as the lead Medical Writing Scientist for complex or pivotal clinical studies
• May be the lead writer for multiple programs or therapeutic areas
• Manage a broad range of Medical Writing activities for development programs with multiple clinical studies
• Participate in developing key messages for highly complex clinical regulatory documents
• Provide leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program
• Provide strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline
• Serve as core member of submission teams for marketing applications, contribute to key message development and submission strategy, prepare clinical summaries and clinical overview
• May assist in preparing nonclinical sections of regulatory submissions
• Ensure information from team meetings and key messages are incorporated appropriately across documents
• Contribute to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents
• Provide expert review of documents
• Proactively identify process and template improvements.
• Provide expert-level input to cross-functional teams that work on standard operating procedures, process improvements, and integration of new tools and technologies
• May train, mentor, and supervise staff in the Medical Writing department
• Perform other duties as assigned
TECHNICAL AND COMMUNICATIVE SKILLS:
In addition to the skills of Senior Medical Writing Scientist:
• Outstanding written communication skills
• Extensive experience writing and editing clinical regulatory documents
• Ability to analyze, interpret, and summarize highly complex data
• Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
• Ability to mediate conflicts by negotiating, compromising, persuading, and facilitating the open exchange of ideas and opinions
• Highly developed project management and organizational skills
• Ability to manage challenging, high-value projects
• Initiative and creativity in solving complex problems; ability to have a substantial role in developing and implementing improvements in cross-functional processes.
- Ph.D. (or equivalent degree) and 4+ years of relevant work experience
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.