Sr Manager, Regulatory Affairs, Advertising & Promotion
Company: Horizon Therapeutics
Location: Mount Prospect
Posted on: June 11, 2022
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.
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
- 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
- Provides expert guidance to help evaluate and mitigate
- Serves as an internal expert on FDA regulations, guidance, and
enforcement trends governing the promotion of prescription drug and
- 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
- 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
- Provides expert guidance to help develop material review
processes for cross-functional teams and high visibility
- 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
- 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
- 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
- Understanding of clinical study design and statistical
analyses, and their importance in the assessment of claims Strong
- Must be solution-oriented and embrace Horizon's culture and
approach to product communications
- Must be detail-oriented and able to manage multiple
- Skilled in written and verbal communications
- Proficient in Microsoft Office
- Professional, proactive demeanor
- Strong interpersonal skills
Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- 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, Mount Prospect , Sr Manager, Regulatory Affairs, Advertising & Promotion, Advertising , Mount Prospect, Illinois
Didn't find what you're looking for? Search again!