Senior Manager, Content Strategy & Development (Medical Writing) - Protocol Lead

Gilead Sciences • Foster City, CA

1d

About The Position

At Gilead, we are dedicated to creating a healthier world by tackling diseases like HIV, viral hepatitis, COVID-19, and cancer through relentless therapy development and global access. Every team member contributes to scientific innovation, and People Leaders are crucial for fostering an inclusive, developed, and empowered employee experience. The Gilead Regulatory Affairs team is comprised of highly skilled professionals focused on efficiently delivering therapies to patients worldwide. The Content Strategy & Development (CSD) department, part of Innovation, Content, & Execution (ICX) within Regulatory Affairs, drives the strategy and creation of high-quality documents for regulatory submissions. CSD is an inclusive and diverse community that supports individual development and work-life balance. This Senior Manager role offers a unique opportunity for a regulatory medical writer to specialize in protocol development, working collaboratively with cross-functional teams to lead large clinical programs and document strategy.

Requirements

• Bachelor's Degree and Eight Years’ Experience OR Masters' Degree and Six Years’ Experience OR Ph.D.
• PharmD/PhD with 4+ years’ relevant experience.
• MA/MS/MPH/MBA 6+ years’ relevant experience.
• BA/BS with 8+ years’ relevant experience.
• Significant content strategy and development, regulatory, quality, clinical R&D, or related experience supporting medicinal products.
• Significant experience in the biopharma industry is strongly preferred.
• Experience authoring a broad range of regulatory, scientific, medical and other business content across multiple stages of drug development.
• Knowledgeable of regulatory document requirements/guidelines with direct experience in a wide variety of regulatory document types.
• Well-developed computer skills including proficiency in Word, Adobe, Excel, and the Regulatory Document Management System.
• Direct experience in protocol authoring or management is highly preferred.

Nice To Haves

• Knowledge of AI and other emerging technologies to complete medical writing or related deliverables is preferred.

Responsibilities

• Lead the development of protocols and amendments for CSD (Medical Writing) in the Oncology therapeutic area, including development and management of timelines and resource planning, supporting large clinical programs.
• Oversee internal and external medical writers on protocols and amendments to ensure the highest quality of medical writing and adherence to Gilead content and quality standards.
• Independently author a wide variety of clinical/regulatory documents such as protocols and amendments, ICFs, CSRs (all phases), and IBs according to regulatory requirements and internal Gilead document standards.
• Author high complexity documents such as integrated CTD summaries/overviews, PSPs, PIPs/PIP modifications, or regulatory responses with some input from a more senior CSD team member.
• Participate in development/improvement of document standards, templates, and processes and other non-medical writing activities.
• Effectively communicate with a variety of teams and individuals.
• May coach, train, and provide mentoring and guidance to less experienced writers.
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Benefits

• Discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)
• Paid time off
• Company-sponsored medical insurance
• Company-sponsored dental insurance
• Company-sponsored vision insurance
• Company-sponsored life insurance plans

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees