Regulatory Operations Associate I

Regulatory Operations Associate I Department/Division: Biotech/R&D/Science Job Type: Full Time, Employee Company: Vertex Pharmaceuticals Inc. Location: US-MA-Boston Job Reference Id: 1117   Description: Posting Title: Regulatory Operations Associate I Location: Cambridge, MA Department: Regulatory Classification: Clinical Research Required Travel: No Required Education: Bachelors Degree Relocation: Yes Job Description Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Position Overview: The Regulatory Operations Associate I will provide general support and assistance within the department. This individual will contribute to document formatting /word processing activities and publishing clinical study reports. Assignments may include assisting with compiling and maintenance of regulatory submissions. Key Responsibilities: - Documentation formatting and word processing according to Vertex's approved style guide and documentation standards - Assist in the preparation of regulatory submissions following instructions from supervisor - Coordinates the availability of submission supplies for both paper and electronic regulatory submissions. - Responsible for the collection, scanning, filing in EDMS, and submission preparation of references and publications for paper and/or electronic submissions. - Supports publishing of clinical study reports for the Medical Writing Department and the preparation, publishing, submission, maintenance, tracking, and operational coordination of paper and electronic global regulatory submissions throughout a products lifecycle. - Performs data entry, filing, archiving, and maintenance of submission tracking databases for several of the active drug programs. - Contribute to electronically formatting documentation (i.e. building PDF Hypertext links and bookmarks), and the performance of other important tasks for electronic regulatory submissions, as assigned. - Performs other duties, as assigned. Minimum Requirements - 0-2 years in pharmaceutical/biotech industry, preferably Regulatory Affairs - Proficient in Adobe Acrobat, ISI Toolbox, MS Word (v2003), and MS Excel. - Experience with Adobe Acrobat, ISI Toolbox, EDM systems (Documentum), Liquent's Core Dossier and ISI eCTDXpress, ISI Publisher, Documentum, and DocXTools/DocXamine desired. Minimum Education Requirements Bachelor's Degree in Life Sciences, Business Administration, Information Technology or related field Apply Now