Director, Global Medical Services Operations (East Coast Based Position)

Job Description Summary:

The Director, Global Medical Services Operations, enhances the provision of premium medical services and underlying processes that are fundamental to success. Critical to both internal and external customers, Medical Services is a vital support function that contributes towards the successful utilization of PTC products. Working with colleagues, and cross-functionally with internal departments, external resources, and vendors, the incumbent implements, directs, coordinates, monitors adherence to, and improves essential processes, based on regulatory requirements, as well as company policies, goals and objectives.
The Operations Director, Global Medical Services supports Regional Heads with adherence to relevant regulatory requirements and compliance with company Standard Operating Procedures (SOPs) as appropriate, to ensure a continued state of inspection readiness.
They enhance the effectiveness of our external relationships and collaborations with essential third parties, stakeholders and resource providers, who are central to the continuous delivery of a high quality, scalable and efficient service that can adapt and grow in alignment with business needs.

*** Candidate must be based on East Coast******

Job Description:

Responsibilities:

• Maintains active oversight of the entire Medical Services inquiry handling operations across all regions; ensuring a global state of continuous inspection readiness.
• Increases the efficiency of existing processes and procedures to enhance the optimization and success of service delivery.
• Recognizes process improvement opportunities and implements changes to boost service, infrastructure, and human resource effectiveness.
• Identifies non-adherence to processes swiftly and proactively proposes and implements strategies to optimize and refine processes that are inefficient, cumbersome, or obsolete.
• Builds close relationships with cross-functional teams to improve communication and establish best collaborative practices that enable stakeholder functions to fulfil their regulatory obligations. This includes establishing solid connections with Compliance, Legal, Pharmacovigilance and Quality departments (and other stakeholder functions) to ensure that activities and processes remain consistently aligned with, complementary to, and add value to, the respective obligatory functional requirements. This expectation applies at a global, regional, and local country level. Examples include complying with GxP activities, and all applicable safety, quality, and data privacy legislation, whilst also considering company policies and local codes of conduct where necessary.
• Assumes global responsibility for contracting, managing, and monitoring, third party vendors that are partnered with the company as additional resource to deliver core Medical Services. This includes supporting regional medical services leads with onboarding contractors, launching new front-line contact centers, or expanding the scope of services currently in place with existing vendors.
• Implements, maintains and monitors the core service delivery and quality; working with regional Medical Service leads to identify, understand, correct, and improve, any issues, risks, resource limitations, or process and/or system barriers that are detriment to service quality and efficiency.
• Establishes appropriate, and globally consistent, workflows for Medical Services inquiry handling or triage by partner organizations, who may, or may not be the local MAH for a PTC product or products.
• Leads the preparation and execution of internal and external audits and inspections, where Medical Services activities are included in the scope of impacted functions.
• Manages the validated global medical information database, including training users, user access, new release impact assessments and user acceptance testing.
• Manages publication access and library services including the copyright license, journal subscriptions and publication access tools and vendors.
• Overseas all activities related to functional records management obligations, including retention scheduling, review and disposition. 
• Manages, supports, or contributes to, specific allocated Medical Services projects and resources.
• Assumes accountability for operational related budget requirements.

• Supports second-line Medical Services when resource capacity is stretched. This may include conducting literature searches or creating custom responses in response to unique inquiries and supporting internal business projects that require the added value of Medical Services insights and expertise.
• Identifies and informs management of any issues that may jeopardize the delivery of premium Medical Services, or PTC’s products or business.
• Keeps abreast of industry and functional developments (e.g. local, regional and global legislation and regulations), new technology and innovative service delivery channels.
• Participate in meetings to increase awareness of Medical Services and available information.
• Deputizes for the Global Head of Medical Services in their absence when required.

Qualifications:

Bachelor’s degree in pharmacy or scientific discipline and minimum of 10 years’ experience in a core medical services role, plus significant experience of managing medical services operations at (no less than) a regional level. Experience of leading and participating in medical information audits.  Experience of managing GxP validated systems.

• Experience of medical information operational management at a global level within the pharmaceutical industry
• In-depth working knowledge of relevant pharmaceutical industry codes and legislation relevant to medical information.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Deep understanding of the diverse business functions and principles of a pharmaceutical company (such as, Pharmacovigilance, Quality Assurance, Medical Affairs, Compliance, and functions within the commercial side of the business).
• An analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. 
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. 

Special knowledge or skills and/or licenses or certificates preferred.

• Experience of medical operational management at a third-party vendor organization, to which medical services operations are outsourced. Experience on both sides of such a partnership is advantageous.
• Advanced degree (Pharm D, PhD, Masters).

Travel requirements: 10%

Flexibility to work different time zones as needed

Expected Base Salary Range:

 $209,100 – $263,200.   The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Click here to return to the careers page