Associate Director, Global Labeling

Alnylam is seeking an experienced labeling professional to join our labeling strategy team. This team is responsible for developing initial product label content and strategy through the Target Label Process (TLP). The ideal candidate will possess expertise in drafting label content and leading cross-functional teams within a larger development framework. In this role, you will work closely with labeling operations, compliance teams, and various internal stakeholders.

Key Responsibilities

• Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams as appropriate.
• In collaboration with Global Regulatory Leads and Core Labeling Teams (CLTs): create, revise, and maintain Company Core Data Sheets (CCDS) for Alnylam's products.
• Develop labeling strategies and Target Label Profiles.
• Provide strategic guidance to Core Labeling Teams regarding new and revised labeling regulations, competitor labeling, and labeling trends.
• Review and communicate impact of changes in health authority labelling legislation or guidelines on Alnylam's products[KM1.1].
• Lead with development and maintenance of regional labeling that aligns with the CCDS and meets the requirements of health authorities.
• Lead with preparation of responses to labeling-related queries from health authorities.
• Coordinate labeling activities (e.g., labeling supplements, new labeling development) with internal and external alliance partners as required.
• Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements. Assist with preparation of submissions to health authorities, as needed.
• Track data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in local labeling.
• Support the growth of the Global Labeling function and help design/build systems and processes.

Qualifications

• BS/BA degree (science or related discipline preferred), graduate degree desirable.
• Professional experience in biopharmaceutical industry in fields of Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
• Experience in Regulatory Affairs, including at least 2 years' experience in a Labeling role[KM1.1] responsible for developing and drafting prescribing information content.
• Familiarity with US, EU and Global regulations, standards and guidance documents related to labeling of pharmaceutical products.
• Keep up to date on emerging clinical and other data, product safety, changes in manufacturing, and completion of post-marketing commitments and requirements for Alnylam products that may trigger changes to the CCDS and regional or local labeling.[KM2.1]
• Must be detail-oriented and able to multi-task and manage multiple projects.
• Skilled in written and verbal communications.

U.S. Pay Range

$170,900.00 - $231,300.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.