Manager, Medical Writing - Informed consent forms (ICF's)

Description de l'emploi

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 living with life-threatening diseases around the world.

Gilead has established employee resource groups to support diversity and inclusion, and provides a competitive benefit package including flexible work options and exceptional support for the family and the individual.

www.gilead.com

Medical Writing is a global, dynamic, and diverse team of highly skilled professionals. 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. Medical Writing resides within Regulatory Affairs. 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.

The Role:

We have an exciting and unique opportunity for a Medical Writer to join our dynamic team at the Manager level. You will prepare informed consent forms (ICFs) in support of clinical trials. You will work with cross-functional teams (eg, Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Global Patient Safety, and Clinical Data Science) to deliver documents on time and per team expectations and drive document strategy for Medical Writing.

Key Responsibilities:

• Author ICFs according to regulatory requirements and Gilead internal document standards.
• May participate on cross-functional teams, providing guidance for optimal presentation to achieve document intent.
• Manage document timeline and resource planning with input from a more senior medical writer.
• Manage contractors to ensure the highest quality of medical writing and adherence to Gilead document standards.
• Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.

You Will Need:

• Experience in developing and authoring informed consent forms
• Knowledge of informed consent requirements/guidelines and health literacy principles
• The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams
• The ability to balance integrity and efficiency when managing attention to detail
• Proficiency in the use of Microsoft Office and document management systems
• Bachelor’s degree, or local equivalent, or relevant experience
• Relevant experience includes clinical research and development, regulatory affairs, or related industry/academic experience, with direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment.