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 two years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.
Overview
This is a key role providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy for Insmed marketed and to-be-marketed products
Responsibilities
In close collaboration with Regulatory project leads in the US, EU, and Japan, the Director, Regulatory Labeling will be responsible for creati ng (and/or updat ing ) labeling content , guiding internal review , and facilitating the approval process for labeling content for Insmed marketed and to-be-marketed products, including but not limited to:
CCDS
regional prescribing information ( e.g., USPI , SmPC , Japan PI )
medication guide s
patient information/leaflet/ instructions for use
package labels
RA Labeling will also be responsible for :
c oordinating with multidiscipline team for US commercial implementation strategy
providing labeling input for required postmarketing reporting
managing dedicated labeling system
m aintain ing appropriate labeling SOPs
In general, RA Labeling will:
be responsible for labeling strategy and labeling operations for Insmed marketed and to-be-marketed products
develop project timelines and manag e all labeling projects from initiation to implementation
assess recently approved and/ or comparable product labeling for applicability to Insmed labeling
ensure labeling is compliant with current regulations and guidances, and in line with internal SOP
chair Labeling Working Group meetings
represent labeling group on product sub teams, when applicable
be the primary contact with vendors (e.g., QC ) as needed
participate in labeling meetings with Health Authorities , as necessary
Position requirements:
Bachelor's degree; advanced degree preferred
10 + years experience in the pharmaceutical industry , 7+ years of experience in global r egulatory labeling
Full understanding of the drug development process
Knowledge of global labeling regulations and guidance s
Ability to analyze and solve problems
Ability to work effectively with large cross-functional global teams
Excellent computer skills including high p roficien cy in MS Office and labeling management applications
Excellent verbal and written communications skills
Detail oriented
Excellent organizational and time management skills to manage multiple ongoing projects simultaneously
Travel Requirements
10%
Salary Range
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
The base salary range for this job is from $175,000.00 to $241,667.00 per year
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 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.