Vacature Director

Director, Advertising and Promotion

About Pharming

Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Pharming is committed to our core values: "We Care, We Collaborate, We Walk the Talk", which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

The Director of Advertising and Promotion will be responsible for a wide variety of matters in support of Pharming's growth as we increase the number of both pipeline and marketed products.

Core functions include:

• Serve as regulatory representative on the Promotional Review Committee (PRC), Medical Review Committee (MRC), and the Social Media Governance Council (SMGC).
• Provide regulatory guidance during the development of promotional and scientific materials, external communications related to Pharming's products, and related activities on social media platforms.
• Review and assesses materials for compliance with applicable regulations, guidances, corporate policies/procedures, and consistency with current product labeling.
• Monitor external consultants and agencies responsible for review of promotional and disease awareness materials distributed outside the US.
• Work with ensure product labeling updates are incorporated in promotional materials according to company procedures and regulatory requirements.
• Serves as primary liaison to the FDA for promotional activities, compiles 2253 submissions, and ensures materials are submitted to FDA per regulations.
• Maintains awareness of the regulatory environment related to advertising and promotion, assessing and communicating any relevant changes to internal stakeholders and external marketing agencies.
• Provides training on regulatory promotional compliance to both internal and external audiences as required.
• This is a hybrid role; 2 to 3 days at Warren, NJ office.

Minimum Qualifications:

• Bachelor's Degree.

• 10+ years of experience in Global Regulatory Affairs.
• 8+ years of advertising and promotional experience.
• Experience with health authority interactions.

Preferred Qualifications:

• Prior experience with an EDMS.
• Thorough knowledge of FDA regulations, guidance, and industry standards related to advertising and promotion of prescription drugs, investigational products, and disease awareness activities.
• Work effectively as member of the Global Regulatory Affairs product teams and collaborate with external business partners, including consultants and vendors.
• Ability to work independently in a fast-paced environment, managing and prioritizing multiple projects according to established review timelines.
• Excellent organizational and communication skills, both written and verbal.
• Prior Experience with Veeva PromoMats and Rim is a plus.
• Ability to travel up to 10% is a plus.

Compensation & Benefits:

• Flexible hybrid work schedule to promote a health work-life balance.
• Competitive compensation package including annual target bonus.
• Long-Term Incentive Program
• 401(k) plan with company match
• Paid-Time Off Days
• 16 Company Holidays per year (typically last week of December up until New Year's Day)

• Excellent Healthcare Plans including Medical, Dental and Vision.
• Flexible Spending Accounts for Medical and Dependent Care.
• Company-provided Life Insurance, Short-Term and Long-Term Disability Plans.
• Accident, Hospital Indemnity and Critical Illness Plans.
• Pet Insurance Plan.
• On premise Fitness Center.
• Health & Wellness Program.
• Choice of Mobile Phone for Work Use or Cell Phone Stipend.
• Pharming Academy - Continuing Learning & Development Program.

Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to .

Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Functie:	director
Startdatum:	26-10-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Pharming via onbekend of onbekend. Of bezoek hun website onbekend.