Senior Manager, Us Medical Ad/Promo Regulatory Review

4+ years

108,500.00 - 170,500.00

Lexington

10 Dec. 31, 2024

Job Description

Job Type: Full Time Education: MD/PhD/PharmD/MBA/MS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The job description you provided is for a Senior Manager, US Medical Ad/Promo Regulatory Review at Takeda, located in Lexington, MA or Exton, PA. This role involves overseeing the regulatory compliance of promotional materials for pharmaceutical and biologic products in the U.S. Here's a summary of the key responsibilities and qualifications for the position:

Key Responsibilities:

Regulatory Oversight:
- Serve as an internal expert on FDA regulations and enforcement trends related to the promotion of drugs and biologics.
- Provide regulatory strategic oversight for assigned products or therapeutic areas to ensure compliance of promotional materials.
- Review and assess promotional materials (ads, press releases, etc.) to ensure completeness, accuracy, and regulatory compliance.
- Evaluate regulatory risks and offer creative solutions, including risk mitigation strategies.
Leadership & Mentorship:
- Mentor and develop staff members, providing technical and regulatory guidance.
- Serve as the chair for promotional review meetings, collaborating with cross-functional teams (Regulatory Affairs, Medical, Legal, etc.).
- Assist with the planning and prioritization of proposed promotional and disease-state materials.
Liaison with Regulatory Bodies:
- Act as the primary liaison with the FDA’s Office of Prescription Drug Promotion (OPDP) and the Advertising and Promotion Labeling Branch (APLB) to negotiate advisory comments and address any promotional claim concerns.
Metrics & Process Improvement:
- Track the effectiveness and efficiency of the promotional review process using established metrics.
- Propose improvements to enhance the efficiency of promotional material review.
Collaboration & Presentation:
- Present regulatory topics, insights, and recent enforcement actions to senior management and cross-functional teams.
- Collaborate with global teams for materials intended for international audiences, ensuring compliance across regions.

Qualifications:

Education: A Bachelor's degree in life science or a related field is required, with an advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
Experience:
- A minimum of 4 years' experience in drug, biologic, or device Regulatory Affairs, including at least 2 years of experience in Advertising and Promotion.
- Strong knowledge of FDA regulations and guidance regarding the promotion of pharmaceutical/biologic products.
- Experience managing regulatory submissions, such as launch advisory comments or responses to enforcement letters.
- Familiarity with global codes of practice and regulations in the pharmaceutical industry.

Additional Skills:

Strong oral and written communication skills.
Excellent negotiation and collaboration abilities.
Prior leadership experience or the ability to manage and bring teams together for common goals.

Travel Requirements:

Some travel may be required, up to 20%, including potential international travel.

Compensation and Benefits:

Salary Range: $108,500 - $170,500 (depending on qualifications and experience).
Benefits: Comprehensive healthcare (medical, dental, vision), 401(k) with company match, vacation days, tuition reimbursement, wellness programs, and more.

About Takeda:

Takeda is a global pharmaceutical company that focuses on transforming patient care through innovative treatments. The company fosters an inclusive, collaborative workplace and is committed to delivering better health and brighter futures for people around the world. Takeda values diversity and offers opportunities for growth and development.

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Senior Manager, Us Medical Ad/Promo Regulatory Review

Job Description

Key Responsibilities:

Qualifications:

Additional Skills:

Travel Requirements:

Compensation and Benefits:

About Takeda:

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