Senior Manager, Document Processing

Senior Manager, Document Processing
United States - California - Foster City
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'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
Document Processing plays a critical role in assisting document authors to ensure all components are presented in the correct format. Document Processing acts as subject matter experts in document formatting, report processing plus document navigation properties, providing cross-functional education, consultation, and guidance to ensure that processing activities are planned and delivered in a manner that meets the highest standards of quality while meeting required timelines.
You may manage a small to mid-size team of direct reports. You will typically be assigned speed-to-market standalone deliverables, such as complex and major marketing applications. You will manage and be accountable for all aspects of the assigned deliverables and submission packages. You will typically be involved in setting departmental strategies and operational plans. You will typically also play an active role in departmental/team assignment, resource allocation and oversight, timeline development, training and development, and interview and selection of Document Processing candidates. You may take a lead role in determining strategies for acquired companies/collaborations/vendors and their on-boarding and integration into Gilead Document Processing operations. You will build strong relationships with internal and external stakeholders and act as a technical expert and lead contact in advising cross-functional groups on Gilead and regulatory document formatting, report processing and technical specification requirements. You will lead special projects, such as initiatives and/or updating procedural documents or other tools used by Document Processing.
EXAMPLE RESPONSIBILITIES:

• Performs or otherwise oversees and guides a variety of routine and non-routine Word and PDF formatting, including ensuring team members appropriately utilize Document Processing supporting tools for submission-ready documentation.
• As needed, oversees and guides filing and data retrieval functions in conjunction with departmental standard operating procedures (SOPs).
• Leads or otherwise promotes current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
• Ensures timely and appropriate interface between team members and projects managers, regulatory product managers, and/or content authors to discuss documentation preparation and content.
• Typically acts as the lead Document Processing representative in submission planning meetings.
• Ensures timely and appropriate workflows and procedures regarding document tracking, indexing, retrieving, and disseminating of regulatory agency submissions as defined by Regulatory Operation management.
• Ensures that regulatory documents comply with the relevant guidelines for content and format and that the content of the document is accurate and reflects the information / data in the source documentation.
• Guides other team members with respect to content and format requirements and quality control procedures.
• Identifies and records issues that require resolution prior to finalization and liaises with responsible authors to resolve issues.
• Assists authors in the completion and compilation of regulatory documents to ensure all components are provided and presented in the correct format.
• Leads special projects, such as continuous improvement or other Document Processing initiatives.
• Coaches and mentors other Document Processing team members and helps on-board and train new team members in Document Processing practices, policies, procedures, processes, systems, and other tools.
• May have one or more direct reports and/or manage and oversee vendor resources.
• Develops and delivers Document Processing training, communications, and other tools for Document Processing team members and/or cross-functional teams and partners.
• As needed, assists with coordination of non-routine projects, strategy development, and on-boarding of acquired companies and their staff.
• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience

• PharmD/PhD with some relevant experience.
• MA/MS/MBA with 6+ years' relevant experience.
• BA/BS with 8+ years' relevant experience.
• 3+years' experience in regulatory submissions, including electronic document and report processing and experience working with electronic document management systems in a regulatory environment
• Significant experience working with a broad array of regulatory submissions, documentation management systems, and processes, including speed-to-market standalone deliverables and major marketing applications hard copy and electronic regulatory documents and reports.
• Experience contributing to the development of regulatory strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple submissions is strongly preferred.
• Experience working with regulatory agencies in different markets.
• Experience successfully leading departmental and cross-functional teams without authority.
• Experience authoring and implementing processes and leading other special projects.
• Line management (direct reports) experience is preferred.
• Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.

Rest of World Education & Experience
BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry. Significant regulatory submissions or related experience.
Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Demonstrated ability to lead a team and development of individual team members.
• In-depth knowledge of regulatory submissions requirements and guidance, including industry best practices and standards.
• Working knowledge of the drug development process.
• Demonstrates understanding / knowledge of Gilead Quality standards and tools and Gilead's products and pipeline.
• Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
• Ability to train new or less experienced colleagues in standard regulatory document and report processing activities, including policies, requirements, templates, systems, databases, and other tools.
• Ability to advise new or less experienced colleagues in resolving standard issues associated with regulatory document operational activities.
• Ability to advise cross-functional partners internal and external on standard regulatory requirements and pathways needed to meet regulatory and other business goals and objectives.
• Ability to lead and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly matrixed environment.
• When needed, ability to travel.

The salary range for this position is: $154,020.00 - $199,320.00. 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 ApplicantAccommodations@gilead.com 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.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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