Business Operations Specialist, Medical Writing Team

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

About Gilead Sciences International, Ltd.

Gilead Sciences International, Ltd. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need, including virology, oncology, and inflammation.

Job Summary

We are seeking a highly skilled Senior Associate, Medical Writing Business Operations Specialist to join our global, dynamic, and diverse Medical Writing team. As a key member of our team, you will play a critical role in advancing our strategy and creating high-quality documents for successful regulatory submissions.

Key Responsibilities

  • Serves as one of the primary points of contact for department scheduling of projects, ensuring timely resource allocation in accordance with business needs and vendor outsourcing strategies.
  • Collaborates with senior team members to implement resourcing strategies, driving efficiency and effectiveness in our operations.
  • Participates in automation and optimization of resourcing processes, leveraging technology to streamline our workflows.
  • Routinely monitors the inbox and resourcing tool, responding to general queries and serving as a liaison between team members, stakeholders, and vendors.
  • Engages with vendor business managers and vendor staff as needed, participating 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, providing valuable insights to inform our business decisions.
  • Efficiently manages contractor onboarding and offboarding, providing input on relevant training roles.
  • Reviews vendor invoices for accuracy and tracks vendor utilization, ensuring transparency and accountability in our operations.
  • Typically does not develop project timelines, but understands timeline inputs and deliverables, facilitating document handoff and completion delivery as needed.
  • Participates in team meetings by presenting vendor updates, outsourcing metrics, and other relevant topics.

Requirements

  • Understanding of the drug development process and regulatory document landscape.
  • Experience with clinical regulatory documents is preferred, with relevant experience in technical data review or scientific review in biotechnology or pharmaceutical industries.
  • Responsive and diplomatic communication skills, with the ability to prioritize competing tasks and projects.
  • Ability to understand the needs of various teams and individuals, manage expectations, and use various communication styles to work effectively with teams.
  • 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)

Gilead Sciences International, Ltd. is an equal opportunity employer, committed to recruiting, selecting, and employing the most qualified persons available for positions throughout the company, without regard to protected characteristics or prohibited grounds, including 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.

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