Sr. Medical Writing Scientist
The Senior Medical Writing Scientist is responsible for preparing moderately complex clinical study documents and sections of regulatory submissions. The Senior Medical Writing Scientist may assist other
Medical Writing staff to prepare more complex documents and may assist with developing documents produced by other departments. The Senior Medical Writing Scientist contributes scientific knowledge and analytical skills to the preparation of clinical regulatory documentation. Works under minimal supervision.
• Advance those of Medical Writing Scientist to include the following:
• Prepare moderately complex clinical regulatory documents, including clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions
• Serve as the lead Medical Writing Scientist for moderately complex clinical studies
• Support Medical Lead with review and interpretation of clinical study data and addressing questions from study team members
• May coordinate Medical Writing resources for a clinical development program
• Participate in developing key messages for moderately complex clinical regulatory documents
• May represent the Medical Writing department on teams responsible for defining the direction and regulatory strategy for a clinical development program
• Ensure medical and scientific consistency between related documents or studies in a clinical program
• Thoroughly analyze and critically interpret data to determine the best approach to composing each document
• Provide more advanced input for study designs, analysis plans, and statistical output
• Provide advanced review of documents
• As part of a cross-functional team, contribute to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serve as coordinating author for product development plans
• Provide input and support for advisory board meetings for clinical development programs
• May assist in preparing grant applications
• Participate in developing standard operating processes and related procedures
• Manage contract medical writers
• May train, mentor, or supervise staff in the Medical Writing department
• Perform other duties as assigned
Minimum Qualifications :
• Master's Degree or Ph.D. and 3 – 5 years of relevant work experience
• Superior written communication skills
• Experience writing and editing clinical regulatory documents
• Ability to analyze, interpret, and summarize moderately complex data
• Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
• Ability to manage project teams, form productive working relationships, and work through conflicts
• Excellent project management and organizational skills
• Ability to prioritize and manage multiple complex projects
• Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues.
• Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process
• Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools.
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.