Principal Medical Writing Scientist

9897BR","ActualValueFromSolar":null},Department Medical Writing ","ActualValueFromSolar":null},Posting location Boston, MA ","ActualValueFromSolar":null},Job Title/Position Title Principal Medical Writing Scientist","ActualValueFromSolar":null},Posting Job Title Principal Medical Writer","ActualValueFromSolar":null},Job Description

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.



KEY RESPONSIBILITIES:



Prepare complex clinical regulatory documents, including clinical study protocols, clinical study reports, and investigators 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.

","ActualValueFromSolar":null},Minimum Qualifications

* Ph.D. (or equivalent degree) and 4+ years of relevant work experience

#LI-KF1","ActualValueFromSolar":null},Full-Time or Part-Time Full-Time ","ActualValueFromSolar":null},Company Information

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 .



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 .