Medical Operations Senior Manager, Evidence Generation and Publications
Company: Exact Sciences
Location: Redwood City
Posted on: June 8, 2021
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
- 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
- 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
- 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
- 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
- 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
- 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
- Excellent written and verbal communication and presentation
- 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.
- 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
- 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
- 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
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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