The Medical Writing (MW) Operations Associate ensures quality review of clinical and regulatory documents and MW process documentation. The MW department plays an integral role in producing scientifically accurate, high-quality clinical documents throughout the drug development process.
- Performs advanced editing, formatting, fact-checking, and content quality control reviews of regulatory and clinical study documents (e.g., clinical study reports and protocols, Investigator's Brochures, and regulatory submission modules) according to department guidelines
- Works with other functions to collect, file, and track appendices for clinical study reports using the electronic document management system (eDMS)
- Provides troubleshooting and training to all levels on key MW processes and systems
- May develop and update SOPs, work instructions, templates, and checklists
- May supervise or lead MW initiatives related to document development, quality, and improvement (such as managing systems, collecting and analyzing metrics, or developing and implementing new tools)
- Communicates ideas for new processes and/or business operations for process improvement
TECHNICAL AND COMMUNICATIVE SKILLS:
PREFERRED EDUCATION AND EXPERIENCE:
- Outstanding attention to detail related to consistency, grammar, and accuracy according to source documentation
- Working knowledge of Microsoft Office (including Word, PowerPoint, and Excel)
- Previous experience with eDMS, electronic Common Technical Document (eCTD) Viewer, Good Clinical Practice (GCP), and the AMA Manual of Style is a plus
- Ability to complete work in a resourceful, self-sufficient manner, with some guidance and mentoring on new or complex issues
- Exhibits sound judgement and decision-making in a dynamic, regulated environment
B.A. (or equivalent degree) with 1 to 2 years of relevant work experience preferred
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, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
Vertex is consistently recognized as one of the industry's top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. 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.