Senior Labeling Project Coordinator
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Seen as a labeling expert across Regulatory, Legal, Graphic Designers, Package Engineering, Quality Assurance, and Materials Management functions.
Contributes to the completion of all operational activities projects where prior precedents may not be set and outcomes require operating without prior experience.
Manages the most complex processes across functions and interacts effectively with the other team members to ensure product labeling implementation timing is met.
Responsible for the coordination of implementing new labeling with Materials Management and at multiple sites.
Based on novel approaches to existing processes, recommends improvements and develops systems/SOPs to enhance labeling operations.
KNOWLEDGE, EXPERIENCE AND SKILLS
Proficient knowledge of Good Manufacturing Practices (GMPs).
Strong verbal, technical writing and interpersonal skills.
Proficient in Microsoft Office applications.
Possesses a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
6+ years of relevant experience and a BS or BA.
4+ years of relevant experience and a MS.
Prior experience in pharmaceutical industry is preferred.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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