Project Development Associate

1 month ago


Uxbridge, United Kingdom Gilead Sciences, Inc. Full time
Job Title: Senior Associate, Medical Writing Business Operations

Location: Cambridge or Stockley Park

Gilead Sciences, a research-based biopharmaceutical company, is seeking a highly skilled Senior Associate to join its Medical Writing Business Operations team. As a key member of the team, you will play a critical role in advancing the company's strategy and creating high-quality documents for successful regulatory submissions.

The Medical Writing team is a global, dynamic, and diverse group residing within Global Regulatory Affairs. We work collaboratively to bring 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.

Key Responsibilities:

  • Serve as a primary point of contact for department scheduling of projects, ensuring timely resource allocation and vendor outsourcing strategy.
  • Collaborate with senior team members to implement resourcing strategy and participate in automation and optimization of resourcing processes.
  • Monitor the inbox and resourcing tool, responding to general queries and acting as a liaison between team, stakeholders, and vendors.
  • Engage with vendor business manager(s) and vendor staff as needed, participating in meetings, taking minutes, and delivering feedback.
  • Perform Quality Assurance activities to ensure vendor work complies with Gilead document standards, with input or supervision as needed.
  • Update department metrics with supervision and efficiently manage contractor onboarding/offboarding.
  • Review vendor invoices for accuracy and track vendor utilization.
  • Participate 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, 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, 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, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.



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