- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Associate Director, Regulatory Affairs, Labeling - Boston, United States - Gilead Sciences
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Description
Associate Director, Regulatory Affairs, Labeling page is loadedAssociate Director, Regulatory Affairs, Labeling
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locations
United States - Massachusetts - Boston
time type
Full time
posted on
Posted 4 Days Ago
job requisition id
R
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
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At Gilead, we're creating a healthier world for all people.
For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We empower our leaders to step up, share ideas, listen, learn, and lead.We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged.
We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
Join Gilead and help create possible, together.Job Description
Job Description
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures.
Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers.
Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies.
You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the oncology therapeutic area.
You will lead various Core Labeling Working Group (CLWG), Target Product Label (TPL), and U.S. Product Information (USPI) team meetings. You will represent RA Labeling across all organizational levels relevant to assigned products and/or other activities. You will manage complex labeling negotiations with regulatory authorities. You will communicate labeling and other relevant updates or changes to cross-functional leaders and teams.You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
You will train cross-functional partners and teams on labeling processes, policies, procedures, standards, etc.EXAMPLE RESPONSIBILITIES:
Leads or otherwise contributes to the development of the labeling strategy for multiple products and indications in the oncology therapeutic area.
Provides strategic advice and guidance to cross-functional partners and stakeholders.
Leads and facilitates cross-functional labeling and related forums and meetings, such as CLWG, TPL, and USPI team meetings.
Leads or otherwise contributes to key system and process improvements.
Represents or otherwise oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on joint labeling / safety meetings with partner companies.
Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories. Performs team and/or final review of ex-U.S. labeling.
Manages complex labeling negotiations with regulatory authorities.
Coaches and advises less experienced colleagues in completing their work and developing their regulatory capabilities.
Leads or otherwise contributes to special projects that advance the capabilities of Regulatory Affairs.
Trains other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling.
Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.
Position will be filled as a Senior Manager or Associate Director, based on candidate experience.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
PharmD/PhD with 4+ years' relevant experience.
MA/MS/MBA with 8+ years' relevant experience.
BA/BS with 10+ years' relevant experience.
4+ years' experience in prescription drug labeling.
Significant regulatory experience in the biopharma industry is strongly preferred.
Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products.
Significant experience contributing to the development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple medicinal products.
Significant experience participating in cross-functional projects and teams.
Experience authoring and implementing processes.
Experience working within the virology therapeutic area and varying stages of drug development is strongly preferred.
Knowledge & Other Requirements
In-depth knowledge of labeling requirements and guidance, including industry best practices and standards.
Demonstrates extensive understanding of competitor labeling, strong therapeutic area knowledge, and CCDS/USPI expertise.
Demonstrates ability to rapidly learn new therapeutic areas.
Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.
Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
When needed, ability to travel.
The salary range for this position is: $161, $209, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For additional benefits information, visit:
United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or
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information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.
Gilead Sciences, Inc.
is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.#J-18808-Ljbffr