Sr. Manager - Public Disclosure and Transparency
Company: Horizon Therapeutics
Location: Mount Prospect
Posted on: June 18, 2022
Job Description:
Working at Horizon is more than a job - it's personal. For us,
success is measured by the numbers that matter most - the number of
lives we touch, the number we change and those we work tirelessly
to help save. We're a team of agile, out-of-the-box thinkers who
are inspired to do more because we know we're a part of something
bigger. We strive to build meaningful careers at a company whose
values we share because when we live up to our potential, we help
others live up to theirs. Position Summary:The primary
responsibility is to oversee the completion of activities for all
Horizon-sponsored clinical trials to comply with Global regulatory
requirements for posting clinical trials on public websites (e.g.,
ClinicalTrials.gov, EudraCT, etc.) and reporting transfers of value
to prescribers and other healthcare providers.Responsibilities:
- Coordinate all activities related to clinical trial data
sharing, publication of lay summaries, and redaction of trial
documents according to Global regulations by performing these
activities internally and/or managing selected vendors.
- Liaise with clinical study teams, attorneys, corporate
communications, etc. to ensure timely and accurate information is
agreed upon and released to the public.
- Remain up to date on Global Regulations and plan, coordinate,
and prepare for internal presentations to ensure knowledge transfer
to clinical study team members.
- Complete or manage Global reporting of transfers of value to
prescribers and health care providers.
- Liaise with multiple vendors to ensure consistent reporting
across all clinical studies and ensure proper filing of related
finalized documentation.
- Manage vendors as needed to support activities of the
department.
- Act as the subject matter expert during regulatory
inspections.
- Review and update existing SOPs, guidelines, or work
instructions and identify opportunities for process
improvement.
- Participate in training and educational opportunities for
personal development and cross-training within the
organization.
- Manage and mentor direct reports to ensure consistency across
departments.Qualifications and Skills Required:
- BA or BS (or equivalent ex-US) degree
- 7+ years experience managing Global Public Disclosure and
Transparency activities
- 2+ years' overseeing direct reports
- Strong knowledge of the life science industry
- Has familiarity with US FDA, ICH/GCP, and European Regulatory
Authority requirements as applicable to a study (or the countries
where a study is conducted).
- Strong analytical and problem-solving skills
- Ability to learn quickly and adapt to system and technology
changes
- Proficient in Microsoft Office, Adobe Acrobat, SharePoint, and
clinical systems
- Professional, proactive demeanor
- Strong interpersonal skills
- Excellent written and verbal communication skills Horizon Core
Values & Competencies: Growth
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent Accountability
- Drives Results
- Ensures Accountability
- Decision Quality Transparency
- Courage
- Collaboration
- Instills Trust Horizon requires all U.S. employees to be fully
vaccinated, as a condition of employment, with either Pfizer (fully
approved by the U.S. Food and Drug Administration), Moderna or
Johnson & Johnson (currently granted emergency-use authorization by
the FDA). "Fully vaccinated" is defined as two weeks after your
final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine.
Horizon will provide medical and religious accommodations as
required by law. Horizon Therapeutics plc does not discriminate on
the basis of race, color, religion, gender, sexual orientation,
national origin, age, disability, veteran status, or any other
characteristic protected by law. It is our intention that all
qualified applications are given equal opportunity and that
selection decisions be based on job-related factors. Any
individual, who, because of a disability, needs accommodation or
assistance in completing this application or at any time during the
application process, should contact the Human Resources
Department.Required
Keywords: Horizon Therapeutics, Mount Prospect , Sr. Manager - Public Disclosure and Transparency, Executive , Mount Prospect, Illinois
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