Sr Manager, Regulatory Affairs, Advertising & Promotion
Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: May 13, 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:
Provide a regulatory review of communications about Horizon's
marketed products and disease areas to healthcare providers,
patients, payers, and other audiences, with the objective of
ensuring they comply with U.S. laws and regulations and Horizon's
policies while supporting the achievement of business
objectives.
Responsibilities:
Collaborate with colleagues in Commercial, Legal, Medical Affairs,
and other expertise areas in the creation of promotional and
disease awareness communications, field training materials, and
materials and communications used in scientific exchange, for
assigned product(s) Provides expert guidance to help evaluate and
mitigate potential risks. Serves as an internal expert on FDA
regulations, guidance, and enforcement trends governing the
promotion of prescription drug and biologic products. Establishes
relationships with management and key partners (Marketing, Medical,
Legal, Compliance, Sales Training, Managed Care, Corporate
Communications, etc.) encouraging mutually helpful interactions and
exchange. Maintains awareness of labeling updates to communicate
impact and relevance within Regulatory Organization. Highlights
important facts in a clear and concise manner. Develops and guides
implementation strategies for promotional activities Broadly
applies regulatory/technical knowledge of government regulations
and skills across therapeutic areas. Ensures training and
compliance with established regulations, guidance, promotional
guidelines, and SOPs related to advertising and promotion
regulations. Effectively delivers difficult messages to
cross-functional partners without damaging relationships.
Prioritize workload based on Business Unit needs and ensure timely
and complete submissions. Provides product development and label
development strategies, as needed, to ensure promotional claims can
be supported Mentors student interns and PharmD Candidates by
leading projects during internships and rotations to help provide
an impactful and meaningful experience in the pharmaceutical
industry Provides expert guidance to help develop material review
processes for cross-functional teams and high visibility materials
Develops labeling materials specific to advertising and promotion,
such as DTC and HCP Brief Summaries, to expand the commercial
advertising capabilities for approved products Presents regulatory
and compliance training to company representatives and speaker
bureau prior to medical conference exhibit, speaker programs, and
similar interactions Consistently evaluates regulatory landscape
and industry promotional standard to develop best practices for
consistency across business units Initiates and/or contributes to
process improvements for activities that relate to the RA Ad/Promo
group and the broader organization Work closely with Regulatory
Operations in making timely submissions of promotional materials to
FDA Provide Regulatory Strategy and Global Labeling colleagues with
input into clinical study designs and labeling claims that will
support commercial objectives Participate in educating the
organization on the U.S. regulatory framework and enforcement
environment for advertising and promotion of prescription drugs and
biologics
Qualifications and Skills Required:
A Bachelor's degree in science (BS) required. Advanced degree
(PharmD, PhD, or JD) preferred. Minimum of 5-7 years of
professional experience in the biopharmaceutical or related
industries, with at least 3 years of Regulatory Affairs advertising
and promotion experience. (Fellowship experience may be
substituted) Knowledge of U.S. laws, regulations, guidance
documents, enforcement actions, and industry standards related to
communications about prescription drugs and investigational
treatments Understanding of clinical study design and statistical
analyses, and their importance in the assessment of claims Strong
interpersonal skills Must be solution-oriented and embrace
Horizon's culture and approach to product communications Must be
detail-oriented and able to manage multiple priorities Skilled in
written and verbal communications Proficient in Microsoft Office
Professional, proactive demeanor Strong interpersonal 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, Regulatory Affairs, Advertising & Promotion, Advertising , Buffalo Grove, Illinois
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