Medical, Legal, and Regulatory Specialist

Help us change lives

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Medical, Legal, and Regulatory (MLR) Specialist supports the MLR team by working closely with the internal stakeholders, and external agencies to ensure that project goals are met through excellent coordination and communication. Administrative duties, such as preparation of meetings agendas, documentation of meeting minutes, and project-related activities may also be required.  This role will coordinate reviewers across the business to meet company timelines. This role will work with leadership across all functions (including, but not limited to, Marketing, Medical Affairs, Corporate Affairs, Clinical & Regulatory Affairs, Compliance, Sales Effectiveness, and Commercial Enablement) to ensure timely and accurate review of advertising and promotional material to meet internal guidelines and requirements. They will lead the intake and Quality Control process for all submissions.  This role is also responsible for proactively identifying process and system enhancements through our electronic content management system (ECMS).

Essential Duties

Include, but are not limited to, the following:

• Acts as a liaison between internal and external stakeholders of the MLR process to ensure timely and accurate review of advertising and promotional material meets internal guidelines and requirements.
• Partner with Medical, Regulatory Affairs, Legal and Commercial to assess and determine need for process review of materials.
• Manage the ECMS submission process to ensure all content metadata and deliverables are included within project requirements.
• Schedule and lead MLR meetings, prepare agendas, and consolidate meeting minutes at the direction of Leadership.
• Responsible for coordinating and holding weekly and ad-hoc meetings.
• Manage multiple shared inboxes related to the MLR process.
• Responsible for creating weekly reports that will be sent out to all functions within the MLR area.
• Maintain organized project management related information and provide to appropriate stakeholders.
• Facilitate timely reviews and approvals by coordinating with internal and external teams.
• Coordinate and provide communication updates to user groups, management, and project teams.
• Perform Electronic Content Management System (ECMS) trainings to new system users.
• Establish and maintain positive relationships with cross-functional stakeholders and team members.
• Prioritize and balance multiple competing priorities within and across multiple projects at the same time.
• Contribute to a continuous learning and process improvement environment.
• Proofread and check documents for accuracy as well as consistency.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor’s Degree in business administration or field as outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 4 years of experience in lieu of Bachelor’s degree.
• 2+ years of experience working in commercial (sales, marketing, commercial operations), compliance, or related field.
• 1+ years of experience in material review (MLR) specific collaborative and matrixed environment.
• Demonstrated success with oral and written communications/presentations, results orientation, facilitation, and teamwork skills.
• Basic computer skills to include Internet navigation, Email usage, and word processing.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Previous experience managing a time sensitive process.

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Salary Range:

122 000,00 zł - 201 000,00 zł

The annual base salary shown is for this position located in PL - Warsaw on a full-time basis. This range reflects base salary only. The position may also be eligible for a discretionary bonus under applicable company plans.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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