Director, Medical Writing (Process)

Director, Medical Writing (Process)
United States - California - Foster CityUnited States – RemoteUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. 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’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

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

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description


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 Director level. You will work within the Medical Writing team to create a central process, template, and training capability to support the strategy, development, and maintenance of medical writing processes and templates. You will collaborate with cross-functional teams (eg, Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Global Patient Safety, and Clinical Data Science) to ensure medical writing processes, templates, and trainings that support the delivery of high-quality documents and adhere to regulatory guidance and industry standards.

Key Responsibilities:

• Oversee all activities related to the development and maintenance of medical writing processes and templates.
  
• Assess and implement changes to medical writing processes and templates based on emerging regulatory guidance and industry standards.
  
• Optimize medical writing processes and templates and ensure adherence to Gilead documentation standards.
  
• Lead or oversee cross-functional initiatives to improve quality and/or efficiency process for medical writing processes and templates to achieve company objectives.
  
• Be the subject matter expert, providing specialist medical writing expertise for development of processes and templates for clinical/regulatory documents as well as various training methods.
  
• Coordinate and support change management and training on medical writing processes and templates for all internal and external stakeholders.
  
• Provide centralized management for all process-related Medical Writing initiatives.
  
• Participate in complex companywide initiatives.
  

You Will Need:

• Expert knowledge of global regulatory affairs, particularly the regulatory documentation requirements and mechanisms of the United States and Europe.
  

• Experience in a senior role in a medical writing environment, directing and preparing documents for regulatory submissions. Experience of document management, authoring, and publishing tools would be an advantage.
  
• Proven track record of successfully managing large scale, complex, time-sensitive projects.
  
• Leadership skills and presentation skills to influence, negotiate, and collaborate with teams for any medical writing process and template initiatives.
  
• Issue resolution skills, being able to manage cross-functional teams through complex processes given clear direction.
  
• Strong negotiation and conflict resolution skills.
  

• Bachelor's degree or higher, or local equivalent, or relevant experience.
  
• Relevant experience includes clinical research and development, regulatory affairs, or related industry/academic experience. Experience in a senior role in a medical writing environment is preferred, as well as experience in directing and preparing documents for regulatory submissions.
  

The salary range for this position is: $199,835.00 - $258,610.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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.






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