Associate Director, MLR Operations Excellence (Lead)
General Scope and Summary
Sage Therapeutics is searching for a highly organized, process focused, strategic business partner to lead our internal review processes and serve as material review process business owner for our electronic review systems in lockstep with our IT partners.
Roles and Responsibilities (Essential Functions)
This role will acquire management and oversight of our MLR Review processes and systems from the Regulatory Advertising and Promotion function to build out capabilities, manage Material volume, support business priorities, leverage metrics and analytics capabilities, maintain the health of the MLR review environment, serve as a Senior member of the Supervisory MLR Committee, present to the Executive Review Committee as needed, and build out resources for the MLR Operations Team. Responsibilities include:
Lead the MLR Review Process operations function working in close collaboration with key internal stakeholders to deliver approved MLR Materials across the organization
Attend MLR meetings as Chair to facilitate the meeting, keep the team focused, resolve, or escalate disputes, move the meeting forward, set the pace, and establish meeting culture
Build a highly effective MLR operations team to support multiple investigational and marketed programs including partner collaboration reviews
Set vision and direction for MLR Review Process in partnership with Legal/Medical/Regulatory (MLR) and other Commercial business partners
As part of Sage’s collaboration with Biogen, collaborate to build and manage efficient joint MLR / PMRC process
Work with IT business partners on system maintenance, configuration updates, and enhancement prioritizations
In partnership with MLR Material contributor’s drive early planning and evolve current forecasting process (materials)
Collaborate with MLR Stakeholder teams to plan and prioritize material development and review
Inform stakeholders of activity relative to MLR, Print, and Fulfillment by providing quarterly utilization metrics and analysis that need to be built for Sage
Oversee the day-to-day operations of a the MLR operations coordinator, including but not limited to, Veeva submissions, QA of materials, and facilitating MLR meetings
Lead/participate in development, onboarding, and training of new hires of Commercial, Reviewer teams and 3rd party vendors
Work cross-functionally with MLR Sage Owners, Owners (3rd party vendors), and reviewers to escalate issues and expedite business critical items as needed
Strategic oversight and execution of key MLR operations tactics, which include: Strategic planning in collaboration with Sage MLR business contributors, MLR Reviewers, Supervisory MLR Committee, Executive Review Committee (ERC) as needed, vendor management, contracting, and tactical execution, tracking and reporting on all metrics
Effectively communicate and collaborate across internal cross-functional teams and with stakeholders to ensure successful execution and alignment on accountabilities
Strategic understanding of KPIs / metrics related to med comms / promomats
Identify the opportunities to improve business practices and processes to maximize resources and achieve operational excellence across MLR operations initiatives
Experience, Education and Specialized Knowledge and Skills
This section details the education level, experience, knowledge and skills needed to be successful in the role and is separated into Basic Qualifications (what is necessary) and Preferred Qualifications (what is ideal).
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to identify issues and raise to key stakeholders to maintain key deadlines and deliverables for the organization
BS Degree in a related field
6+ years of experience leading multifaceted programs and initiatives
List any additional education, experience, competencies, certifications, etc. that would be deemed “nice to have” and may allow the incumbent to achieve a higher level of success in the role.
8-10 years of experience leading multifaceted programs and initiatives
Knowledge of Veeva Vault or similar systems
Commercial and Medical Department/functional knowledge
Excellent interpersonal skills/highly collaborative
Ability to cultivate strong internal/external network
Strong operational skills; project/timeline management capabilities
Effective stakeholder management and problem-solving skills
Experience in cross functional review management for Promotional and/or Medical Materials
Experience working with all levels of management and consulting with key business stakeholders with an ability to influence for greater outcomes.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Possesses strong written and verbal communication skills.
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of Sage.
Experience with co-promote / commercial collaborations
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.Employment Type:EmployeeNumber of Openings:1Job ID:R000934#Biotechnology #Careers #ThisIsSage
All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.