Senior Associate, Medical Writing Business Operations Specialist

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 resourcing in accordance with business need and vendor outsourcing strategy.
  • Collaborates with senior team members to implement resourcing strategy, participating in automation and optimization of resourcing processes.
  • Routinely monitors the inbox and resourcing tool, responding to general queries and acting as a liaison between team, stakeholders, and vendors.
  • Engages with vendor business manager(s) 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.
  • 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, 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 biotechnology or pharmaceutical industries.
  • Responsive and diplomatic communication skills.
  • Ability to prioritize competing tasks and projects.
  • Ability to understand the needs of a variety of 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 and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees and job applicants.



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