Sr Manager, Public Disclosure and Transparency
Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: May 10, 2022
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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.
Keywords: Horizon Therapeutics, Buffalo Grove , Sr Manager, Public Disclosure and Transparency, Executive , Buffalo Grove, Illinois
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