Vertex Pharmaceuticals

Manage and oversee global regulatory submission projects, ensuring timely and compliant filings, risk management, and team leadership. | Bachelor's in life sciences or related field, 10+ years in project management within life sciences, 2+ years supervisory experience, expertise in regulatory content planning tools. | Job Description The Associate Director, Regulatory Submission Management is responsible for the planning, managing and tracking of the regulatory portfolio of submissions across a number of assigned programs. This role will be responsible for driving comprehensive plans and reports that would include all major milestones and other key dates related to the filings. The role will focus on achieving regulatory submission activities and driving the broader GRA team to ensuring all deliverables are met. This role will be responsible for driving timeline risk mitigation and contingency planning. This is a remote role - Eastern time zone work hours Key Duties and Responsibilities: Oversees complex project and portfolio plans from project initiation to closeout. Drives the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements. Oversees the development of project plans, status reports, issue logs, and other project-related artifacts. Leads strategies for risk mitigation and contingency planning within plan. Efficiently identifies and resolves project issues within the team and drives the resolution to completion. Manages project status, issues, schedule and accomplishments and communicates to various management and stakeholder groups, as needed. Leads and manages members of submission management team. Leads the preparation of necessary reports to drive data-driven resource, budget and trade-off discussions across the GRA function. As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff. Knowledge and Skills: Expertise in global regulatory filing project management Expertise in project management tools Expertise in using Veeva Rim for content plan submissions Comprehensive understanding of types of Global HA submissions and requirements and guidelines Ability to drive firm deadlines and adapt quickly to changing requirements and priorities Excellent organization, written/verbal communication, and attention to detail to persuade managers and leaders to take action Stakeholder management skills Ability to balance multiple tasks to meet priorities and timelines Supervisory/management experience Education and Experience: Bachelor’s degree in life sciences or technology area Typically requires 10+ years of project management experience in regulatory/clinical project management or project management experience in a life sciences company and 2 years of supervisory/management experience, or the equivalent combination of education and experience Pay Range $90-$100/hr Requisition Disclaimer This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com. If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email. No C2C or Third-Party Vendors

Manage and maintain all document and knowledge management processes for Patient Support Programs, including document creation, control, compliance, and team collaboration. | Bachelor's degree with 5+ years healthcare/pharmaceutical experience, knowledge/document management program experience, technical writing skills, proficiency in documentation and project management tools, and strong collaboration skills. | Job Description General Summary The Senior Manager, Knowledge Management Contractor, sits in the Program Quality Team in Vertex’s North America Commercial Patient Support Center of Excellence (NAC PS COE) and is responsible supporting multiple disease area Patient Support Programs in the strategy, development, and updating of all critical standard operating procedures and work instructions. Reporting to the Director of Program Quality, the Senior Manager will play a meaningful role within the PS COE Program Quality Team and will support all aspects of knowledge management. **This is a 6 month contract Key Responsibilities: Responsible for all document management and maintenance for the NAC Patient Support Department and management of team who: Creating and Maintaining Documents: ensuring the Patient Support team’s 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 PS, across other team stakeholders, and in the Vertex Document Management System (VDMS) 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 PS Glossary and ensuring alignment with product and/or Corporate lexicons Work as part of a team of Document Managers who specifically support a particular PS teams’ knowledge management needs Implement and manage WI and SOP standard review processes with Business SME’s, Legal, and OBIE Responsible for various weekly and monthly reporting and reconciliation to internal & external stakeholders In collaboration with the Program Quality Director, provide insights and trends related to Knowledge Management to Vertex Legal, OBIE and NAC PS leadership Responsible for contributing to NAC PS team training related to Knowledge Management Identify and drive process improvements for the PSP team and support roll-out of new initiatives across functions as appropriate and in collaboration with other team members under the guidance of the Director Identifies and escalates critical process issues related to Knowledge Management appropriately to Director Act in complete and total compliance with all laws, regulations and Vertex policies Other responsibilities as assigned by the Director Minimum Qualifications #LI-SO1 Bachelor’s Degree and 5+ years of experience in the healthcare/pharmaceutical industry Experience managing a Knowledge or Document Management program 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 Advanced 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, seeks to understand and self-educate on current trends in the healthcare and payer market Intellectually curious with a continuous improvement and problem-solving mindset Preferred Qualifications: Experience in patient focused programs with associated HIPAA regulations and other legal parameters and patient privacy policies Patient-centric and customer service-minded Experience in Patient Support organizations Experience supporting both GxP and non-GxP processes Willingness to work in a fast-paced environment and have the ability to multi-task and self-prioritize workload Attention to detail and committed follow-through in communication to internal and external partners Excellent written communication skills, presentation delivery as well as strong interpersonal skills Pay Range TBD Requisition Disclaimer This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com. If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email. No C2C or Third-Party Vendors

Lead clinical trial medical oversight, develop study protocols, ensure safety and scientific integrity, and collaborate with cross-functional teams. | MD/DO or equivalent medical degree with 8+ years clinical research experience, expertise in clinical trial design, regulatory submissions, and safety monitoring. | Job Description General Summary: The Clinical Development Associate Medical Director generalized myasthenia gravis (gMG) will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting. In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary Medical Monitor accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity. The incumbent may participate in other projects to support the clinical development program. Key Duties And Responsibilities • Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidance • Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution • Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate • Provides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports • Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies • Represents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study results • Performs other duties as assigned related to other aspects of Clinical Development Knowledge And Skills • Strong oral and written communication skills • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate • Global clinical research experience and experience interacting with regulatory authorities is a plus • Working familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical development • Board certification/eligibility, as well as clinical training in a relevant medical specialty is highly desired Education And Experience • MD, DO or equivalent ex-US medical degree • Typically requires 8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience Pay Range $198,300 - $297,400 Disclosure Statement The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status In this Hybrid-Eligible role, you can choose to be designated as: • Hybrid: work remotely up to two days per week; or select • 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. 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

Drive quality outcomes and operational excellence for GLP processes, collaborate on quality indicators, support regulatory reviews and audits, and contribute to inspection readiness and training. | Bachelor's degree in scientific field, strong GLP experience, pharmaceutical or CRO background preferred, ability to work independently, and excellent communication skills. | Job Description: The GLP Operational Quality Manager/Sr. Manager supports quality oversight for the GLP-related processes and activities. The incumbent will support business partners and GLP Operational Quality to drive quality outcomes and operational excellence, through supporting operational management oversight for these areas. The GLP Operational Quality Manager/Sr. Manager will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. The Manager/Sr. Manager, GLP Operational Quality will also collaborate with the Quality Analytics team to review and support the development of meaningful quality indicators to permit ongoing evaluation of process and quality system health and identification of risks. Job Description We are seeking a dedicated and experienced Good Laboratory Practice Quality Manager/Sr. Manager to support our company's quality oversight for GLP-related processes and activities. As a GLP Quality Manager, you will collaborate with various stakeholders and the GLP Operational Quality team to drive quality outcomes and operational excellence. Your primary responsibility will be to ensure compliance, excellence in quality, and readiness for future needs. Key Responsibilities: • * Support the GLP Operational Quality team and business partners in driving quality outcomes and operational excellence. • Maximize the value, impact, and delivery of quality oversight activities to ensure compliance and excellence in quality. • Collaborate with the Quality Analytics team to develop meaningful quality indicators for ongoing evaluation of process and quality system health, as well as risk identification. • Work closely with other R&D Quality members to support scalable quality approaches and ensure consistency in execution across products and programs. • Participate in regulatory document reviews, identifying potential risks or gaps in Investigator Brochures, INDs, BLAs, and NDA's. • Provide input in the development of audit scope and focus for vendor audits. • Contribute to pro-active inspection readiness activities by conducting quality assessments of GLP studies either on-site or remotely. • Collaborate with preclinical stakeholders and quality partners to develop appropriate metrics related to GLP activities. • Participate in creating and presenting content for annual GLP refresher training. Perform other duties as assigned. Requirements: • * Bachelor's degree or equivalent in a related scientific field. • Strong experience in GLP (Good Laboratory Practices) and reviewing data and documents supporting GLP studies and submissions. • Experience in Pharmaceuticals or Contract Research Organization (CRO) • RQAP-GLP certification is preferred, but not mandatory. • Ability to work independently and meet timelines in a fast-paced environment. Excellent communication and collaboration skills. Travel Requirements: This role may require up to 20% travel. Travel primarily includes visiting CROs for conducting Quality Reviews focused on data reviews. Some travel to Boston may be required for training or stakeholder engagement. Pay Range: $75-$85/hr Requisition Disclaimer: This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com. If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email. No C2C or Third-Party Vendors