Senior Associate, Medical Writing Business Operations
3 months ago
Description
Job Title: Senior Associate, Medical Writing Business Operations
Location: Cambridge or Stockley Park
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.
Gilead has established employee resource groups to support and provides a competitive benefit package including flexible work options and exceptional support for the family and the individual.
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. May evaluate document review scope and estimate required review time. Escalates to more senior team members if special document strategy is needed. 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 participate in meetings, taking minutes, following up on action items, delivering feedback, escalating issues, and coordinating training refreshes. May perform Quality Assurance activities to ensure vendor work complies with Gilead document standards, with input or supervision as needed. 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. Typically does not develop project timelines; however, understands timeline inputs and deliverables and standard timelines. Facilitates document handoff and completion delivery as needed. Escalates timeline negotiations as needed. Participates in team meetings by presenting vendor updates, outsourcing metrics, and other relevant topics.You Will Need:
An understanding of the drug development process and regulatory document landscape. Experience with clinical regulatory documents is preferred. Relevant experience could include technical data review or scientific review experience in biotechnology or pharmaceutical industries. 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, manage expectations, and use various communication styles to work effectively with teams. The ability to continuously anticipate and solve problems, as well as adapt to changing priorities and ambiguity. Proficiency in Microsoft Office suite (including Word, Visio, Project, PowerPoint, Excel, and PowerBI), as well as Adobe Acrobat, SharePoint, Smartsheet, and a regulatory document management system such as Veeva.Education & Experience
BA/BS or advanced degree in life sciences or related field with some related work experience in the biopharma industry, e.g., clinical R&D, regulatory affairs, quality, or other related discipline.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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