Senior Associate, Medical Writing Business Operations Location:
Uxbridge, United Kingdom Client:
Gilead Sciences International, Ltd. Job Description:
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients around the world living with life-threatening disease. Medical Writing is a global, dynamic, and diverse team residing within Global Regulatory Affairs. We work collaboratively to advance the strategy and create high-quality documents for successful regulatory submissions, by bringing our passion for science, discovery, and innovative strategic thinking into our daily work. Our team of highly skilled Medical Writing and Quality Review professionals support the authoring and quality review for a variety of clinical and regulatory documents. We are dedicated to attracting new talent with diverse backgrounds and experiences and committed to providing individual development and growth opportunities while promoting a healthy work-life balance. Key responsibilities include: Serves as one of the primary points of contact for department scheduling of projects. Ensures projects are resourced in a timely manner in accordance with business need and vendor outsourcing strategy. Collaborates with more senior team members to implement resourcing strategy. Participates in automation and optimization of resourcing processes. Routinely monitors the inbox and resourcing tool. Responds to general queries and acts as a liaison between team, stakeholders, and vendors. Engages with vendor business manager(s) and vendor staff as needed. May perform Quality Assurance activities to ensure vendor work complies with Gilead document standards. Updates department metrics with supervision. Efficiently manages contractor onboarding/offboarding and provides input on relevant training roles. Reviews vendor invoices for accuracy and tracks vendor utilization. Participates in team meetings by presenting vendor updates and outsourcing metrics. You Will Need: An understanding of the drug development process and regulatory document landscape. Experience with clinical regulatory documents is preferred. Responsive and diplomatic communication skills. The ability to prioritize competing tasks and projects. The ability to understand the needs of a variety of teams and individuals. The ability to continuously anticipate and solve problems. Proficiency in Microsoft Office suite and regulatory document management systems. Education & Experience: BA/BS or advanced degree in life sciences or related field with some related work experience in the biopharma industry. Equal Employment Opportunity (EEO): It is the policy of Gilead Sciences, Inc. to recruit, select and employ the most qualified persons available for positions throughout the Company.
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