- Develop and implement comprehensive strategies and the operating model for innovating and leading the end-to-end process for scalable scientific content that includes the creation, approval, and disposition of non-promotional materials used in external communications the healthcare, patient, and scientific communities.
- Identify or develop new solutions to support the automation of content creation and reuse for multi-channel delivery by leveraging generative AI, component authoring, and other technologies to scale these efforts.
- Oversee procedural documents (ie, standard operating procedures [SOPs], Work practices). Collaborate with therapeutic area Medical Affairs teams, Medical Information, Regulatory, and Legal to ensure adherence to regulatory requirements, industry standards and compliance with organizational policies and procedural documents in all aspects of medical review activities.
- Identify opportunities for process improvement with the scientific content ecosystem, utilizing data-driven approaches and stakeholder feedback. This includes coordinating and collaborating with the Medical, Scientific Communications, Legal, Regulatory leadership on execution of core projects related to process improvements and system enhancements.
- Partner with Medical Governance, Legal, Regulatory, and Medical Affairs leadership to establish protocols for quality assurance and monitoring of all aspect of medical approval and fulfillment activities, conducting audits and evaluations to maintain high standards of accuracy and reliability
- Guide and coordinate vendor activities, including oversight of MRC coordinators and other 3rd party resources to support the operating model
- Develop and deliver training to ensure that all content owners and reviewers are trained properly on the MRC process and other processes or technologies to support the scientific content ecosystem.
- Responsible for the development metrics and KPIs to measure the efficiency, productivity, quality, and use of the medical content created by Medical Affairs. Present findings to senior management with recommendations for further improvements to meet established KPIs.
- Assist with budget planning, forecasting, and managing accruals. Analyze resource utilization, forecast future needs, and develop strategies to optimize resource allocation to maximize efficiency and productivity.
- Bachelors Degree required: Doctor of Pharmacy Degree (PharmD) or Scientific/Medical Degree preferred
- 10+ year of program management experience leading medium to large scale initiatives; experience working in Medical Review Committee Operations is preferred
- 10+ years of medical affairs operational experience or medical/scientific communications experience
- Strong project management skills with proven ability to prioritize, conduct, and meet project deadlines. Mastery of specific Project Management methodologies a plus (e.g., Lean, Six Sigma, PMP certification, etc.)
- Experience with Veeva Vault MedComms and Veeva CRM and partnering with IT colleagues to implement system enhancements
- Excellent verbal and written communication skills as well as strong interpersonal and tactful negotiation skills
- Proven ability to exercise problem solving and strategic thinking skills; and has foresight and judgment in making complex decisions
- Experience developing Policies, Standard Operating Procedures (SOPs), Work Practice Documents, etc.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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Sr. Director, Global Medical Content Management - Foster City, United States - Gilead Sciences, Inc.
Description
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
Gilead Sciences, Inc., a leading biopharmaceutical company dedicated to creating a healthier world for over three decades, focuses on developing innovative medicines to combat life-threatening diseases such as HIV, viral hepatitis, and cancer.
With operations spanning more than 35 countries, Gilead is headquartered in Foster City, California, and is committed to advancing medical breakthroughs to improve patient lives globally.
We aim to be a trusted source of unbiased, personalized, evidence-based clinical decision support for Gilead's medicines provided through seamless multi-channel experiences to improve patient outcome.
Job Overview:
In this new role, you will be responsible for developing and leading a new strategy and operating model for the Medical Affairs scientific content ecosystem at Gilead including the creation, approval, and disposition of non-promotional materials used in external communications with HCPs, Patients, Patient Advocacy Groups, and other Healthcare organizations.
In this role, you will develop solutions to support the innovation and automation of content creation and reuse for omni-channel delivery by leveraging tools and technologies (ie generative AI, component authoring, etc), to scale these efforts.
You will collaborate with Medical Affairs Technology and Medical Excellence personnel, Legal and Regulatory personnel and Medical Affairs colleagues to evolve our content oversight, management and CRM platforms to enable an efficient review and approval of materials, ensure the proper storage and fulfillment of materials, and track how of our medical content is used externally.
You will develop metrics to assess efficiency and effectiveness of the MA scientific content ecosystem and use these metrics for continuous improvement and innovation.
This position will also provide oversight and lead the operational support for the Medical Review Committee (MRC) for non-promotional medical materials, ensuring compliance with regulatory standards.
This includes creating and managing all applicable SOPs, working practices/instructions, training materials and ensure that all applicable MRC team members are trained accordingly.
This position reports into the Global Head of Scientific Communications as part of the Global Medical Strategy & Operations organization in Medical Affairs.
Key Responsibilities:
Education and Experience:
The salary range for this position is: $255, $330, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
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:
For jobs in the United States:
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.NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.