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Medical, Legal, Regulatory Review Specialist
Company | Exact Sciences Corporation |
Address | , Remote |
Employment type | FULL_TIME |
Salary | |
Expires | 2023-06-16 |
Posted at | 1 year ago |
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:
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
- Responsible for coordinating and holding weekly and ad-hoc meetings.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Maintain regular and reliable attendance.
- Establish and maintain positive relationships with cross-functional stakeholders and team members.
- Perform Electronic Content Management System (ECMS) trainings to new system users.
- Facilitate timely reviews and approvals by coordinating with internal and external teams.
- Manage multiple shared inboxes related to the MLR process.
- Contribute to a continuous learning and process improvement environment.
- Partner with Medical, Regulatory Affairs, Legal and Commercial to assess and determine need for process review of materials.
- Proofread and check documents for accuracy as well as consistency.
- Manage the ECMS submission process to ensure all content metadata and deliverables are included within project requirements.
- Responsible for creating weekly reports that will be sent out to all functions within the MLR area.
- Support and comply with the company’s Quality Management System policies and procedures.
- Schedule and lead MLR meetings, prepare agendas, and consolidate meeting minutes at the direction of Leadership.
- 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.
- 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.
- Maintain organized project management related information and provide to appropriate stakeholders.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Prioritize and balance multiple competing priorities within and across multiple projects at the same time.
- Coordinate and provide communication updates to user groups, management, and project teams.
Minimum Qualifications
- Authorization to work in the United States without sponsorship.
- 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.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- 2+ years of experience working in commercial (sales, marketing, commercial operations), compliance, or related field.
- 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.
- 1+ years of experience in material review (MLR) specific collaborative and matrixed environment.
Preferred Qualifications
- Previous experience managing a time sensitive process.
If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please email .
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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