Associate Director, Global Labeling Lead
Job Location:
Cambridge, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
About This Role
The purpose of the GlobalLabelinggroup is to driveBiogensregulatorylabelingstrategy and ensure thatlabelingdocuments are of high quality and compliant for the safe and effective use of our products globally.
AsaGlobalLabelingAssociate Directoryou wouldbe responsible fordeveloping thelabelingstrategyleading the development and update of coreEUand USlabelingdocuments and for overseeing implementation at a regionaland local this role you maybe responsible foroverseeing the strategy for other products within your Therapeutic Area.
WhatYoullDo
Leadtimelycreationormanagement of regulatory compliantcompetitiveand up to date core EU and USlabelingdocuments throughout the product lifecycle including theTarget Label ProfileCore Data SheetEUSmPCand USPI
Leadthecross functional productLabelingTeam to reach consensus onlabelingmatters accuratelycaptureand communicate decisions and obtain endorsement by senior management
Critically assess the data and propose thelabelingstrategy to be followed in core EU and USlabelingdocuments ensuring alignment with globalregionaland localregulatory strategies
Oversee distribution and tracking ofCore Data Sheetupdates for assigned products ensuring compliance ismaintainedwithin the Electronic Document Management System and theRegulatoryTrackingSystem
Understand scientific concepts to critically assess clinical data enable proactive interactions with appropriate stakeholders influence the clinical development plan
Develop and implement strategy for global EU and US labeling content
Identify underlying processes and principles for developing product claims representing the risks and opportunities to the project team
Partner with key stakeholders to ensure product labeling is the most current accurate relevant and competitive to inform prescribers and patients
Who YouAre
You will have a passion for strategic regulatory labeling and will be enthusiastic to aid in the evolution of a new labeling department in a growing company. You will havea strong scientific groundingan excellent eye fordetailand a demonstrated understanding of the importance of labeling governance and compliance.
Required Skills
Bachelors degree in a scientific or medically related discipline
6years pharmaceutical/ biotechnology industry regulatory experience includingglobal EU andUSregulatory labeling
Advanced knowledge and understanding of applicable regulations pharmacology medicinepharmacovigilanceand drug development
Experience in interpretation ofglobal EU and USregulations guidelines policy statements etc.
Proven ability to successfully understand regulatory implications of product strategywith regard tothe product labelassessmentand practical management of associated impacts
Demonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterparts
Well organized detail oriented highly effective written and oral communication skills
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
Director
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
