Document Manager, Program Quality Team

Job Description

General Summary

The Document Manager will be part of the Program Quality Team in Vertex’s North America Commercial Patient Support Program Center of Excellence (NAC PSP COE). Reporting to the Senior Document Manager, the Document Manager will play a crucial role within the COE Program Quality Team and contribute to the NAC PSP success through document/knowledge management

This role is responsible for supporting disease area Patient Support Programs (PSPs) in the strategy, development, and revision of program documents including standard operating procedures (SOPs) and work instructions (WIs) in collaboration with multiple stakeholders

Key Responsibilities

• Responsible for effectively managing a robust collection of PSP documents including:
  • Creating and Maintaining Documents: Ensuring the PSP and COE written policies and procedures (Manuals, SOPs, WIs, Job Aids, etc.) are cohesive and reflective of current practices
  • Document Control: storing documents, maintaining version controls, and ensuring appropriate access
  • Technical Communications: Manage WI/SOP/Job Aid documentation style guide, copy reviews and revisions, and formatting needs
  • Document Workflow: facilitate and manage document workflow processes, including within the NAC PSP, across other team stakeholders, and in the Vertex Document Management System (VDMS)/Veeva Vault
  • Compliance: Ensure documented procedures are in line with Vertex and/or external compliance and regulatory standards
  • Knowledge Management: Maintain source of truth for all Program Quality related documents
  • Lexicon Management: Managing and maintaining the NAC PSP Glossary and ensuring alignment with product and/or corporate lexicons
• Working as a member of a team of document managers, this role will support knowledge management through activities including:
  • Implement and manage WI and SOP standard review processes with internal subject matter experts (SMEs) and business partners such as Legal and Privacy
  • In collaboration with the Program Quality Director and Senior Manager, provide insights and trends related to knowledge management to NAC PSP leadership and other stakeholders
  • Contribute to NAC PSP training
  • Identify and drive process improvements for the PSP and support roll-out of new initiatives across functions, as appropriate, and in collaboration with other team members under the guidance of the Senior Manager and Quality Director
  • Identifies and escalates critical process issues related to Knowledge Management appropriately to the Senior Manager and Quality Director
• Act in complete and total compliance with all laws, regulations, and Vertex policies
• Other responsibilities as assigned by the Senior Manager and Quality Director

Minimum Qualifications

• Bachelor’s Degree and 3+ years of experience in the healthcare/pharmaceutical industry
• Document or knowledge management experience including project management, document formatting, and subject matter expert coordination
• Knowledge of or experience with technical writing concepts, including having excellent attention to detail and strong organizational abilities to structure information logically
• Intermediate proficiency in tools such as Microsoft Word, Adobe Acrobat, or other documentation software
• Experience with project management software (e.g., Asana, Microsoft Project, Smartsheets) 
• Strong collaboration skills with a high customer service aptitude
• Intellectually curious with a continuous improvement and problem-solving mindset

Preferred Qualifications:

• Excellent written communication skills, presentation delivery as well as strong interpersonal skills
• Experience supporting both GxP and non-GxP processes
• Experience in patient focused programs with associated HIPAA regulations and other legal parameters and patient privacy policies
• Patient-centric and customer service-oriented
• Willingness to work in a fast-paced environment with the ability to multi-task and self-prioritize workload
• Attention to detail and committed follow-through in communication to internal and external partners

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

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 [email protected]