Senior Medical, Legal & Regulatory (MLR) Specialist

Help us change lives

At Exact Sciences were helpingchange 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 youre working to help others.

Position Overview

The Sr Medical Legal and Regulatory (MLR) Review Specialist will own the International wide (ex-US) process to review and approve compliant advertising and promotional content. This role will work with leadership across all functions (including but not limited to Marketing Medical Affairs Clinical & Regulatory Affairs Compliance and Commercial Excellence) to manage and execute compliant reviews. The Manager will work with their team of reviewers to ensure they are able to complete reviews in a timely manner. They will also be responsible for proactively identifying process and system improvements and managing external vendors and budgets. The MLR Review Manager will partner with stakeholders and team members across International countries.

Essential Duties

include but are not limited to the following:

• Holding cross-functional prioritization meetings.
• Managing the submission process during peak times to ensure all deliverables can be met.
• Partner closely with the Medical Regulatory Affairs Marketing and Training groups to assess and determine the resource needs for review.
• Manage the Electronic Content Management System (ECMS).
• Acts as liaison between internal and external stakeholders of the CRA Process.
• Facilitate timely reviews and approvals by coordinating with internal and external teams.
• Assure timely and accurate review of advertising and promotional material to meet internal guidelines and requirements.
• Implement strategies and solutions to assure all advertising and promotional materials are compliant with requirements and company policies.
• Manage issues and action items collaborating directly with team members to ensure completion.
• Establish and maintain positive relationships with stakeholders and team members.
• Develop systems and processes to organize key project information.
• Prioritize and balance multiple competing priorities including the ability to confront constructively and say no effectively.
• Contribute to a continuous learning and process improvement environment.
• Hold staff accountable to submission processes and level of quality.
• Detail oriented with the ability to 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 companys Quality Management System policies and procedures.
• Regular and reliable attendance.
• 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

• Bachelors degree in Business Administration Legal Studies or related field; or High School Degree/General Education Diploma and 4 years of relevant experience in lieu of Bachelors degree.
• 5 years of experience working in commercial operations marketing compliance or related field.
• Demonstrable ability to lead teams without authority.
• 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.
• Legal authorization to work in the country of employment without current or future sponsorship.

Preferred Qualifications

• Previous experience managing a time sensitive process.
• Previous experience managing a content review and approval process.

Salary Range:

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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