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Medical Operations Senior Manager, Evidence Generation and Publications

Company: Exact Sciences
Location: Redwood City
Posted on: June 8, 2021

Job Description:

Summary of Major Responsibilities

The Medical Operations Evidence Generation and Publications (EG&P) Senior Manager will work with internal partners; including, but not limited to, the medical organization, product lifecycle management and strategy, marketing, other cross-functional teams, and external partners to manage evidence generation strategy development. This role will track and communicate on the tactical execution of clinical studies, analyses, presentations, and the publications for oncology, urology, and next-generation sequencing (NGS). The Medical Operations EG&P Senior Manager will manage the medical organization's efforts to support precision oncology guideline and the Food and Drug Administration (FDA) submissions.

Essential Duties and Responsibilities

  • Collaborate with the medical affairs, medical development, and cross-functional study teams on planning and clinical study design efforts for development, post-market, real-world, and observational studies and support partner identification, selection, and onboard activities.
  • Partner with lifecycle and medical teams to complete ongoing medical evidence gap analyses to identify evidence needs for specific oncology, urology, and NGS guideline groups and other external stakeholders.
  • Remain current with and adherent to the timelines, milestones, and deliverables within the oncology, urology, and NGS evidence generation and publication plans (EGPPs) and proactively communicate setbacks and delays to all relevant parties.
  • Coordinate with the medical communication team on the abstract and publication development activities for the oncology, urology, and NGS EGPPs.
  • Manage the strategy, development, and execution of precision oncology's EGPP.
  • Manage the medical strategy, development, and execution of precision oncology's oncology, urology, and NGS guideline preparedness efforts and submissions.
  • Manage the medical strategy, development, and execution of precision oncology's FDA preparedness and submission efforts.
  • Manage the day-to-day execution of the oncology, urology, and NGS EGPPs, led by the medical affairs team and coordinate regular status update meetings with internal teams, external partners, and vendors.
  • Lead the development, execution, and maintenance of new processes or process enhancements designed to build efficiencies for the evidence generation and publications teams and collaborations with cross-functional partners.
  • Lead the planning and execution of regular cross-functional meetings designed to communicate and align on EGPP activities.
  • Maintain and lead the enhancements to dashboards and other trackers relevant to the scope of work for dissemination and communication to cross-functional teams.
  • Lead the standard operating procedure (SOP) development and refine specific details to the scope of work.
  • Provide input to regular status updates for internal and external stakeholders; including, but not limited to, leadership and cross-functional teams.
  • Ensure that all activities are in alignment with evidence generation and publication team objectives.
  • Develop an in-depth understanding of current products and pipeline technologies.
  • Actively participate as a member of the extended medical organization evidence generation and publication function; including, but not limited to, participate in meetings and teleconferences, and provide clear and timely communication to team members and cross-functional partners.
  • Collaborate and work cross-functionally with the commercial team and other internal stakeholders; including, but not limited to, team members from health economics and outcomes research, marketing, corporate affairs, research and development, clinical and regulatory affairs, pipeline, and investor relations.
  • Apply excellent problem-solving abilities.
  • Ability to read, write, and speak English fluently.
  • Ability to work in a team environment and strong interpersonal skills.
  • Self-starter with the ability to work independently.
  • Strong desire to work in a fast-paced environment where priorities and deadlines can change quickly.
  • Superb attention to detail and strong organizational skills.
  • Excellent written and verbal communication and presentation skills.
  • 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 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 25% of the working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • Bachelor's Degree in Health Sciences, Life Sciences, or related field as outlined in the essential duties; or High School Degree/General Education Degree and 4 years of relevant experience in medical operations or relevant experience as outlined in the essential duties in lieu of Bachelor's degree.
  • 5+ years of experience in healthcare, life sciences, or other related industry.
  • Proficient in Microsoft Office programs to include Word, Excel, PowerPoint, and Project.
  • 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

  • Master's Degree or PhD in Health Sciences or related field as outlined in the essential duties.
  • Experience working with healthcare professionals.
  • Demonstrated understanding of medical terminology and statistics.

#LI-SS1

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.

Keywords: Exact Sciences, Redwood City , Medical Operations Senior Manager, Evidence Generation and Publications, Other , Redwood City, California

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