Manager, Regulatory Affairs Advertising & Promotion

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Job description

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Named Science's Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for three years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists.

Overview

The Manager, Regulatory Affairs Advertising & Promotion will serve as a facilitator on Insmed's Commercial Review Committee and be a member of the committee. In this capacity, the Coordinator will be a participant working within cross-functional teams with representation from Medical, Legal and Compliance as necessary.

Responsibilities

Responsibilities include but not limited to the following:

• Represent Regulatory Affairs on Insmed's Commercial Review Committee providing coordination and meeting facilitation
• Be a member of the Commercial Review Committee (CRC) which will focus on the review and approval of typical Pharmaceutical Advertising & Promotional materials, including but not limited to, Sales Aids, Booth materials, Websites (drug specific, disease state, Corporate), commercial aspects of disease awareness, concepts reviews, commercial training modules
• Facilitate, prepare and process 30 day/2253 submissions to OPDP assuring compliance and on time filing
• Be in house CRC review systems expert, providing training for new users and owning system workflow processes
• Reviews current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed
• Maintains a thorough understanding of FDA's OPDP requirements, as well as a keen awareness of enforcement trends
• Help facilitate any changes made to US Package Insert are appropriately implemented and reflected in current promotions and advertising and participate in similar assessment for ex-US labeling
• Familiarity with all aspects of a Promotional Review Committee process

Qualifications/Requirements:

• Bachelor's degree in scientific discipline; advanced degree a plus
• Minimum of 1 year's relevant work experience in Regulatory Affairs
• Experience interfacing with multiple departments and providing regulatory coordination
• Expertise in FDA's OPDP submission requirements, as well as a keen awareness of guidance/enforcement trends
• Excellent communication skills (verbal and written)
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail-oriented, flexible, and self-starter
• Strong interpersonal negotiation skills and written/verbal communication competency
• Excellent computer skills; Adobe Acrobat are required. Experience in use of Veeva or similar system. Experience with Docubridge or similar publishing system
• Successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies
• Demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
• A self-starter combined with a high energy level and outgoing personality is preferred (ex. Proactively address project hold-ups to move project forward in an efficient manner)

Travel Requirements

Up to 10% travel

Salary Range

67

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

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