Senior MRC Project Manager

Reposted 8 Days Ago
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Alameda, CA, USA
In-Office
170K-242K Annually
Senior level
Biotech
The Role
Lead and coordinate Medical Review Committee (MRC) meetings and processes for review and approval of Scientific Exchange Materials. Manage schedules, agendas, stakeholders, risks, and project planning tools; partner with Medical Affairs leadership and vendors to ensure timely, compliant review and cross-functional alignment.
Summary Generated by Built In

SUMMARY/JOB PURPOSE:

The Senior Medical Review Committee (MRC) Project Manager partners with the GU Portfolio Management in strategic alignment and execution of critical interactions with HCP. Coordinates MRC meetings for discussion and approval of Scientific Exchange Materials to be used with HCPs in alignment with the MRC SOP 054. Brings project management and process expertise to execute a discussion and approval of Scientific Exchange Materials and ensures alignment across multiple stakeholders. Oversees and manages multiple initiatives within Medical Affairs to deliver timely and effective solutions that create significant value across line functions related to the review and approval of Scientific Exchange Materials.

Essential Duties And Responsibilities:

  • Schedules weekly MRC meetings

  • Facilitates committee meetings for the review and approval of Scientific Exchange Materials

  • Liaises with team members to identify agenda items and manages the review schedule

  • Facilitates discussion during MRC meetings to ensure all agenda items are met

  • Coordinates with Document Owners to identify agenda items

  • Liaises internally with members of the company’s functional departments

  • Liaises externally with vendors if needed

  • Strategic planning, management of resources, milestones of MRC meetings

  • Partners with the Medical Affairs Leadership Team in the development, execution and monitoring of review and approval of Medical Exchange Materials plans and tactics.

  • Identifies MRC risks and implements and manages mitigation plans as needed.

  • Keeps stakeholders informed of important changes in each of their respective areas while driving projects within the review and approval of Scientific Exchange Materials.

  • Drives the evolution and development of MRC project planning and monitoring tools.

  • Recognizes and anticipates problems. Translates solutions into viable action plans at a global level that are effectively disseminated and implemented through cooperation of stakeholders.

Supervisory Responsibilities:

  • None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

  • Bachelor’s degree in related discipline and a minimum of nine years of related experience; or,

  • Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

  • Typically requires a minimum of seven years of related experience and/or combination of experience and education/training.

  • Minimum of five years overall experience in the biopharmaceutical/biotech industry and at least three years of direct experience in a Medical Affairs role.

Knowledge/Skills:

  • Comprehensive knowledge in relevant industry/profession and area of specialization.

  • Thorough knowledge in using professional concepts and company objectives to resolve complex issues in creative and effective ways.

  • Identifies and implements methods and procedures to achieve results.

  • Influences the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.

  • Performs a variety of complicated tasks with a wide degree of creativity and latitude.

  • General knowledge of other related disciplines.

  • Applies strong analytical and business communication skills.

    JOB COMPLEXITY:

    Working Conditions:

    • Environment: primarily working indoors, performing clerical work

    #LI-MB1

    If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

    Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $170,000 - $242,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

    In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

    DISCLAIMER 
    The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

    We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

    Skills Required

    • Bachelor's degree in a related discipline
    • Minimum of nine years of related experience or equivalent combination of education and experience
    • Minimum of five years overall experience in the biopharmaceutical/biotech industry and at least three years of direct Medical Affairs experience
    • Project management and process expertise, including scheduling and facilitating MRC meetings and coordinating review/approval workflows
    • Strategic planning, resource and milestone management, and risk identification/mitigation skills
    • Strong analytical and business communication skills
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    The Company
    HQ: Alameda, CA
    1,555 Employees
    Year Founded: 1994

    What We Do

    Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for more than 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too. Please see our Community Guidelines: bit.ly/2XXw9w3 For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

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