The Head of Medical Writing will provide strategic and operational leadership for all Medical Writing activities to support BlueRock’s portfolio, from early development through product registration. Accountable for establishing and overseeing a cohesive, scalable Medical Writing function that delivers high-quality regulatory documents aligned with BlueRock’s global strategy, development timelines, and corporate priorities. Develop and lead an internal medical writing team, oversee vendor partnerships, and serve as a key strategic partner to various departments. Help shape future-state capabilities, including AI-enabled medical writing, platform-based content reuse, and collaboration models with Bayer colleagues. Define and own a Medical Writing strategy and roadmap aligned with BlueRock’s pipeline, regulatory milestones, and long-term growth. Establish standards, processes, and governance to ensure consistency, quality, and inspection readiness across all Medical Writing deliverables. Partner with Regulatory Affairs leadership to ensure integration of Medical Writing into regulatory strategy, Agency engagement, and submission planning. Drive a platform-based approach to document development for efficiencies and content reuse. Represent Medical Writing in cross-company forums as needed. Operational Excellence Provide oversight and accountability for all Medical Writing deliverables across BlueRock’s portfolio. Ensure delivery of documents that are on time, of high quality, and aligned with evolving global regulatory expectations. Identify opportunities to improve speed, quality, and scalability of document development. Lead resource planning (internal FTEs and external medical writing vendors) to support current and future program needs. Oversee and manage vendors and consultants to ensure consistent value, quality, and alignment. Serve as escalation point for complex document development challenges. Build, lead, and develop a high-performing internal Medical Writing team. Provide coaching, mentoring, and performance management to support professional growth and retention. Foster a culture of accountability, collaboration, and continuous improvement. Lead initiatives to modernize Medical Writing activities, including evaluation and pilot implementation of AI-enabled authoring, QC reviews, and content reuse tools. Define and manage collaboration models with Bayer, including potential shared services and/or AI-enabled pilots.

As Director of Clinical Trial Feasibility, Planning, and Analytics within Global Clinical Operations (GCO), you will play a pivotal role in shaping the future of clinical trials at BioNTech. Your work will directly contribute to optimizing operational planning and analytical support for global trials, ensuring alignment with our mission to revolutionize medicine through cutting-edge science. Lead feasibility assessments for global clinical trials, including site selection, patient population analysis, and competitive landscape assessment. Develop country and site-level enrollment projections and timelines, ensuring alignment with protocol design and core project team objectives. Build and maintain forecasting models to support scenario planning, resource allocation, and risk mitigation across the clinical portfolio. Provide operational input during the protocol design phase, ensuring trials are executable, cost-effective, and aligned with core project team objectives. Lead the adoption of advanced analytics, real-world data, and predictive modeling to inform feasibility and planning decisions. Lead implementation and optimization of digital tools and platforms to enhance planning accuracy and efficiency. Track clinical trial performance against expectations, identify areas for potential intervention, and advise cross-functional teams on clinical trial trade-offs across variables such as time, quality, and cost. Partner with CROs on ensuring alignment of assumptions and expectations around feasibility and performance of outsourced studies. Drive the evolution of BioNTech’s feasibility, planning, and analytics capabilities, strengthening internal ownership while optimizing the use of external partners. Establish and embed fit-for-purpose, cost-effective and scalable feasibility and analytics approaches that enhance internal decision-making. Serve as a key point of contact for clinical trial feasibility, planning, and analysis matters. Collaborate with peers in Clinical Operations and cross-functionally with Clinical Procurement, Vendor Management, Clinical Development, Medical Affairs, Regulatory and Project Management to support budgeting, resource planning, and trial prioritization. Participate in root cause analysis and develop mitigation strategies to address study execution and enrollment challenges. Ensure the quality and integrity of feasibility assessments and operational plans, actively identifying and managing internal and external risks. Support the QA team during internal audits, vendor audits, and/or hosting inspections as required. Adhere to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).

Why Oracle NetSuite? At Oracle NetSuite, we believe transformation is not optional—it’s essential. For over 25 years, NetSuite has been at the forefront of cloud ERP innovation, helping more than 30,000 customers run leaner, more agile businesses on a unified, cloud-based platform. As part of Oracle, NetSuite continues to transform how organizations operate by delivering scalable, intelligent solutions without the overhead of legacy on-premise systems. Our teams work hard, move fast, and take pride in delivering real impact for our customers—celebrating wins along the way. About the Role NetSuite Customer Success (CS) is seeking an experienced Principal Consultant to join our Professional Services team focused on Restaurant Hospitality Practice delivery. This role delivers ERP implementations and optimization engagements using the SuiteSuccess methodology for customers across North America. This position sits within the NetSuite Customer Success – Delivery / Professional Services organization and is responsible for leading end-to-end NetSuite implementations, phase upgrades, module deployments, and optimization or health-check engagements that result in high-value, project-based outcomes. As a Principal Consultant, you will operate independently with ownership for overall engagement outcomes, working closely with Project Managers and consulting teams to deliver high-quality, fit-for-purpose solutions. Soft skills and professional maturity are essential—you must be capable of navigating complex client situations and collaborating effectively across internal and external teams. In addition to core ERP delivery responsibilities, this role will increasingly support AI-enabled business transformation by helping customers identify, design, and adopt AI capabilities embedded within NetSuite and integrated business applications to drive efficiency, insight, and measurable outcomes. Key Responsibilities Lead and deliver NetSuite implementation and optimization engagements (SuiteSuccess and tailored deployments) for Restaurant & Hospitality industry customers, ensuring quality, scope adherence, and customer satisfaction. Gather, analyze, and validate customer business requirements and translate them into scalable NetSuite solution designs. Architect and configure NetSuite solutions to meet customer business objectives, including complex workflows, automations, reporting, and integrations. Define detailed functional requirements and collaborate with technical resources (internal teams or partners) to design, test, and deploy integrations and advanced configurations. Support AI-enabled use cases as part of ERP programs, including workflow automation, insights, and decision support embedded within NetSuite and connected applications. Provide leadership and oversight to consultant team members, delegating work while maintaining ownership of overall solution quality and delivery outcomes. Establish strong, trusted-advisor relationships with customers; proactively manage expectations, scope, and risk with professionalism. Apply NetSuite implementation methodology, industry best practices, and internal delivery standards to ensure consistent, repeatable outcomes. Participate in solution scoping, effort estimation, project planning, and knowledge sharing across the Professional Services organization. Maintain up-to-date expertise in NetSuite capabilities, certifications, and emerging platform enhancements. Minimum Qualifications 7 or more years of cumulative relevant experience to include significant ERP solution functional implementation and/or administration. (5–7 years of experience relevant to this position, including 2 years of consulting experience preferred.) Strong ERP functional consulting background with experience leading customer-facing implementations. NetSuite platform experience strongly preferred; experience with competing ERP platforms will be considered. Consulting experience with demonstrated ability to lead workshops, manage stakeholders, and deliver executive-ready communications. Strong written and verbal communication skills. English language read/write/speak proficiency. Preferred Qualifications 2+ years experience implementing AI/ML or generative AI capabilities integrated with business applications (e.g., ERP, CRM, commerce, supply chain, or analytics platforms). Experience designing and supporting integrations using REST APIs, OAuth 2.0, webhooks, JSON/CSV , and ETL/data preparation patterns. Solid data foundations, including SQL, data quality, metadata management, and feature readiness ; familiarity with basic prompt engineering concepts . Working knowledge of data privacy regulations (GDPR, CCPA) and responsible AI practices in enterprise environments. Experience with OCI Generative AI services and/or NetSuite AI features (e.g., Text Enhance, Intelligent Item Recommendations, Demand Planning, AI Connector/MCP). NetSuite certifications (SuiteFoundation, ERP Consultant, SuiteCloud Developer) and/or cloud certifications (OCI or equivalent). Domain expertise in consumer goods, retail, or e-commerce , including pricing, assortment, promotions, inventory, and supply/demand planning. Experience defining KPI frameworks for AI-enabled or automation use cases , such as accuracy lift, cycle-time reduction, revenue growth, or COGS impact. Proven track record leading medium to large ERP programs with cross-functional and technical complexity. Experience mentoring or coaching consultants within delivery engagements. Restaurant & Hospitality industry experience preferred, but not required. Ability to travel as needed. What You’ll Get Opportunity to work remotely while partnering with a dynamic, collaborative NetSuite Professional Services team. Engagements across diverse Products industry customers with complex business challenges and transformation goals. Ongoing professional growth through real-world problem solving and continuous learning at the intersection of cloud ERP, data, and applied AI . Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives. True innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling 1-888-404-2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

We are seeking a detail-oriented Client Planning & Operations Specialist to support the coordination and execution of client plans and event-related logistics. This role focuses on managing timelines, organizing arrangements, and ensuring a structured, seamless experience from initial planning through completion. This is a strong fit for professionals with backgrounds in administration, higher education, healthcare coordination, hospitality, or client services who are looking to apply their organizational skills in a remote environment. Coordinate planning timelines and scheduling milestones Organize confirmations, documentation, and logistical details Support arrangements related to meetings, events, and associated travel components Communicate with vendors and service providers to ensure alignment Maintain accurate records using internal systems Provide professional, responsive communication to clients