Director, Medical Writing - Foster, CA, United States - Gilead Sciences, Inc.

Description

Director, Medical Writing page is loaded

Director, Medical Writing

Apply locations United States - California - Foster City United States – Remote time type Full time posted on Posted 14 Days Ago job requisition id R

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

Job Description

Why Work at Gilead/Additional Information:

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.

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 leadership opportunity for a Medical Writer to join our dynamic team at the Director level. You will join our oncology medical writing team. You will oversee the development of protocols for large, complex clinical studies while supporting wider organizational initiatives. You will lead medical writers and collaborate with cross-functional teams (eg, Regulatory, Clinical Development, Patient Safety, and Biometrics) to deliver high-quality documents on time. You will assist in team budgeting and actively participate in resourcing strategy and meetings. Direct experience in protocol authoring and management is required.

Key Responsibilities:

• Lead the development of protocols and amendments within the Oncology therapeutic area, including development and management of timelines and resource planning, in order to support large clinical programs.
• Be the subject matter expert for protocols and amendments, ensuring all protocol-related deliverables align with regulatory guidance and industry standards.
• Optimize medical writing processes and templates for protocols and ensure adherence to Gilead documentation standards.
• Independently author clinical/regulatory documents in collaboration with key functional contributors.
• Oversee recruitment and manage medical writers and contractors to ensure the highest quality of medical writing and adherence to Gilead document standards.
• May represent Medical Writing on cross-functional initiatives supporting key company objectives.
• May guide authoring teams through document preparation, review, and approval to deliver high‐quality documents to meet project timelines.
• Participate in complex companywide initiatives.

You Will Need:

• PharmD/PhD with 8+ years' relevant experience.
• MA/MS/MPH/MBA 10+ years' relevant experience.
• BA/BS with 12+ years' relevant experience.
• Working knowledge of global regulatory affairs, particularly the regulatory approval requirements and mechanisms of the United States and Europe.
• Leadership skills and presentation skills to influence, negotiate, and collaborate with teams for any medical writing deliverable at the program level.
• Issue resolution skills, being able to manage cross-functional teams through complex processes given clear direction.
• Proven track record of successfully managing large scale, complex, time-sensitive projects.
• Applied knowledge of document management, authoring, and publishing tools.
• Proven abilities to work independently, establishing work priorities and direction, make significant contributions to strategic planning and lead process improvements, as evidenced by past successes effectively managing increasing scope and complexity.
• Proven track record of effective people leadership and management, as evidenced through past effectiveness with employee engagement, development, and retention either with direct reports or through matrix leadership responsibilities.
• Relevant experience includes clinical research and development, regulatory affairs, or related industry/academic experience. Experience in a senior role in a medical writing environment managing staff is preferred, as well as experience in directing and preparing documents for regulatory submissions.

The salary range for this position is: $205, $266, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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