Manager, Regulatory Affairs Advertising & Promotion

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 :

phone number removed)

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 vacation 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 Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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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