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Job Description

This newly created position will support overall Project Management and Strategic Operations (PMSO) activities, which includes support of the QC team, Operations, Project Managers, and Study Monitors. Responsibilities will include nonclinical regulatory document formatting, submission logistics, contract management, document, and data management. Work directly with Preclinical Project Managers, Preclinical Leads, and Regulatory.

Responsibilities

• Work closely with the Study Monitors and Project Managers to develop and maintain nonclinical writing processes, standards, and tools [e.g., SOPs (Standard Operating Procedures), work instructions, templates (Starting Point), style guide, etc.]
• Participate in the preclinical sciences submission team to provide input in various aspects of submission planning and execution. Support will include planning, formatting, compilation, and RIMS entry of nonclinical submission documents intended for regulatory submissions.

• Work across functions and interact with areas beyond the department. Those may include Regulatory Operations and nonclinical subject matter experts (SMEs) from Preclinical Safety Assessment (PSA), Research, Drug Metabolism and Pharmacokinetics and Modeling (DMPK), as well PCS Project Managers and Study Monitors.

• Ensure nonclinical regulatory documents adhere to Vertex standards and regulatory guidelines and ability to identify information gaps and potential issues within nonclinical regulatory documents.
• Support the PMSO team with other department wide projects, contracting, document & data management, and dashboard support.

• Monitor project progress and provide project updates on a consistent basis to various stakeholders about strategy, adjustments, and progress.
• Facilitate project meetings, prepare minutes for select meetings, and track action items.

Knowledge and Skills:

• Experience with formatting nonclinical sections (module 2/4) of regulatory documents, such as Investigator's Brochures (IBs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), as well as nonclinical technical reports.
• Knowledge of relevant nonclinical regulatory requirements including SEND and CTD formats
• Ability to communicate complex ideas clearly and precisely (verbal and written) across project boundaries, influencing others to act and adopt different points of view.
• Ability to build and maintain strong, cross-functional relationships within all levels of the department and throughout the organization.
• Ability to develop and execute plans against overall project goals, identifying key issues and risks for project team and senior level review.
• Ability to apply learnings and standards to improve the planning and execution of future projects.
• Proficiency in Smartsheet and MS Office Suite.

Education and Experience:

• Bachelor’s degree with 2 years of relevant work experience in nonclinical regulatory or pharmaceutical project management. The equivalent combination of education and experience will also be considered.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

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