Sample Operations, Manager

Vertex Pharmaceuticals • Boston, MA

3d • Hybrid

About The Position

As the Sample Operations, Manager, you will act as the day-to-day lead for the Vertex Drug Sample Programs, overseeing operational activities for the direct-to-practitioner sample programs. This position will serve as the key escalation point for field-based employees for all matters related to sampling activities where you will assist, guide and enforce Vertex sampling policies and compliance with the Prescription Drug Marketing Act (PDMA). This role is critical in ensuring sample programs are consistently run in an effective and compliant manner by working closely with third party vendors and internal partners to influence decisions in alignment with organizational goals. This individual will require strong communication, organizational, and effective planning skills to support program changes and improvements to existing systems and processes that will increase efficiency. This position is a hybrid role located in Boston. You must live in the Boston area and be in the office 3 days/week at minimum.

Requirements

• Experience driving service providers to meet contractual deliverables and establish ongoing program improvements and efficiencies
• Proficient in managing process improvement initiatives, identifying gaps, and creating solutions to complex problems that can be implemented quickly
• Ability to develop process flow diagrams, project plans, scoping/business rules documentation, SOPs/Work Instructions & Field Training documentation
• Extremely organized and exerts a high level of self-motivation with the ability to work independently
• Strong written and oral communication, presentation, and stakeholder engagement abilities
• Exceptional attention to detail, project management with the ability to work with cross-functional teams to build consensus
• Ability to work independently and in a team environment to accomplish tasks in a timely manner
• Strong Microsoft Outlook, Word, Excel, and PowerPoint skills are required
• 3+ years of management experience with demonstrated success managing multiple projects, preferably in a pharmaceutical compliance or commercial operations function
• Understanding of Prescription Drug Marketing (PDMA) Act with general knowledge of c GMP, OIG, FDA and other regulatory requirements associated with sample programs
• Bachelor's degree or combination of equivalent education and demonstrated experience in a management role

Nice To Haves

• Preferred experience in sample related role in the life sciences industry

Responsibilities

• Monitor third party vendor activities to ensure adherence with established business rules and service level agreements
• Oversee electronic requests for samples, to ensure samples are successfully delivered to healthcare providers in a compliant manner; ensure sufficient controls are in place
• Provide guidance to management on potential process improvements, compliance matters and their potential impact on organizational effectiveness and business success
• Initiate the development and implementation of standardized work instructions and procedures to help ensure continued compliance with corporate policies
• Support internal and external audits, including PDMA submission packages and FDA compliance documentation
• Respond to Field Representative inquiries timely; proactively follow up on open items and provide detailed information to enforce Vertex sampling policies
• Work with field-based personnel and OBIE compliance partners to resolve potential compliance related matters taking appropriate action and follow up
• Oversee the onboarding and offboarding of field-based personnel to ensure efficient assignment of required training curriculum prior to engaging in sampling activities and to close open activities prior to terminating
• Monitor inventory of drug samples, savings cards, and program materials to ensure adequate supply of inventory and the effective distribution of these items to healthcare providers
• Lead CRM sample module enhancements with IT to configure and implement effective improvements consistent with business objectives
• Develop meaningful metrics and reports to support monitoring initiatives; analyze results to identify patterns and present findings to management making sound recommendations for improvements

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees