Threat Intelligence Specialist Remote Jobs in Pennsylvania (US)
This page tracks remote threat intelligence specialist openings that are location-eligible for Pennsylvania.
This page tracks remote threat intelligence specialist openings that are location-eligible for Pennsylvania.
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Role Description The Workflow Optimization Specialist will drive operational efficiency by designing, implementing, and managing automated workflows and digital solutions using Smartsheet and/or Microsoft 365. This role bridges the gap between business needs and technology, eliminating manual bottlenecks and building scalable, user-friendly systems that empower teams to work smarter. The successful candidate will have a strong understanding of business processes and the ability to translate complex requirements into structured, automated digital solutions. Common objectives will include maintaining high-quality, customer-focused service delivery, ensuring compliance, and preserving transaction accuracy and efficiency. This position will collaborate cross-functionally with colleagues across departments to achieve common objectives. You will: - Solution Design & Implementation - Design, build, and maintain dynamic workflows, dashboards, and automated alerts using Smartsheet and/or M365 tools. - Leverage advanced platform features such as Smartsheet DataMesh, Dynamic View, and Control Center, or M365 tools including Power Automate, Power Apps, and SharePoint. - Translate complex business requirements into structured, automated digital processes. - Experience building complex Smartsheet solutions involving conditional logic, cross-sheet references, and data automation. - Ability to create and manage data-driven dashboards in tools such as Power BI, Tableau, or Excel to visualize project KPIs and performance. - Experience developing and maintaining process maps, flowcharts, and visual documentation to outline current and future-state workflows. - Process Optimization - Audit current operational processes and identify bottlenecks or inefficiencies. - Develop strategies to transition manual, paper-based, or siloed tasks into streamlined digital workflows. - Analyze existing workflows, perform benchmark gap analysis, and assist in the design to transform workflows. - Establish standardization and best practices for platform usage across departments. - Develop processes and procedures to effectively meet or exceed customer expectations. Qualifications - Bachelor’s degree in Business Administration, Information Technology, or a related field. Equivalent combination of education and experience considered. - 2–4 years of experience in business analysis, operations, or process optimization. - Proven hands-on experience building solutions in Smartsheet (Certification highly preferred) and/or Microsoft 365 Power Platform. - Demonstrated experience leading others in process analysis and redesign initiatives. Requirements - Skills & Competencies - Analytical Thinking: Strong ability to map out processes, identify inefficiencies, and design intuitive technical solutions. - Project Management: Excellent organizational skills to manage multiple optimization projects simultaneously, with the ability to prioritize and present status to management. - Communication: Ability to clearly explain technical solutions to non-technical stakeholders and train end users. Must have strong written and verbal communication skills. - Ideal Candidate will possess: - Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors. - Demonstrates initiative, personal awareness, professionalism and integrity, and exercise confidentiality in all areas of performance. - Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA. - Follows OSHA regulations, RadNet and site protocols, policies and procedures. - Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times. Benefits - Pay Range $70,000 - $95,000 per year
If you are proactive, organized, and passionate about delivering a polished client experience, we encourage you to apply.
Role Description We're looking for a customer-focused Travel Concierge Specialist to help clients coordinate personalized travel experiences, reservations, and itinerary details. This fully remote role is ideal for someone who enjoys organization, communication, and providing high-quality support throughout the travel planning process. - Assist clients with travel reservations, itinerary coordination, and booking support - Communicate with clients regarding travel preferences, updates, and confirmations - Coordinate schedules, accommodations, activities, and travel-related details - Maintain accurate client records and booking documentation - Provide timely, professional support to help ensure a smooth travel experience Qualifications - Strong communication and customer service skills - Comfortable working independently in a remote environment - Organized, detail-oriented, and dependable - Comfortable using online systems and digital tools - Travel, hospitality, or client support experience preferred but not required - Must be a citizen of the United States, United Kingdom, Australia, LATAM, and Spain Benefits - Fully remote with flexible scheduling options - Training, onboarding, and ongoing support provided - Opportunity for growth within the travel and hospitality industry - Supportive team environment with structured systems and resources
Beyond Finance is a technology and financial services company that is on a mission to help its clients “move beyond debt.” As an employer, the company is known for its fast-pac
At Beyond Finance, we've made it our mission to help everyday Americans escape the endless cycle of crippling debt and step into a brighter financial future. Through compassionate, individualized care, a culture focused on compliance and ethics, supportive user-centric technology, and customized financial solutions, we've helped over 1 million clients on their path to a brighter future. While we're proud of what we've already accomplished, we're searching for new collaborators to help us get to the next level! If you're looking to join a forward-thinking, rapidly growing organization with helping people as its number one goal, we want to hear from you. About the Role Our Negotiations Specialists play a key role in the success of our clients becoming free of debt. Working on behalf of clients, you will coordinate efforts to help negotiate delinquent accounts for the best possible savings. The ideal candidate will excel in communication and relationship-building with external partners, driving successful outcomes for both our clients and our business. This position offers a unique and rewarding opportunity to make a meaningful impact. What You’ll Do - Establish and maintain strong relationships with external partners to effectively negotiate delinquent accounts on behalf of clients. - Oversee client finances, providing guidance and determining the best strategies for addressing client inquiries and requests. - Utilize various tools and resources to consolidate common debts from multiple clients, enhancing negotiation leverage with agencies. - Demonstrate excellent time management and multitasking skills to efficiently manage account queues. - Consistently exhibit a genuine passion for helping others, with a strong focus on meeting clients' needs. - Participate in additional duties and special projects as required. Qualifications - Bachelor’s degree in a relevant field (e.g., Business Administration, Finance, Banking, Actuarial Science) is preferred. - Exceptional communication skills, including listening, verbal, and written abilities. - Ability to thrive in a fast-paced environment. - Strong commitment to teamwork, collaboration, and fostering an inclusive environment. - A deep passion for assisting others, with a client-focused approach. - Proficiency in technology; experience with Salesforce or similar CRM systems is a plus. The base salary range represents the anticipated salary range for this position. The actual base salary offered within the range will depend on numerous factors including the individual’s skills, experience, performance, and the location where work is performed. In addition to base salary, this position qualifies for commission. Negotiation Specialists earn a monthly commission based on the amount of debt negotiated subject to the terms outlined in the company's commission plan. Full-time employees hired into this position are eligible for health care benefits shown here. Base Salary Range $21—$21 USD Why Join Us? While you make a difference for others, we’ll work to make a difference for you, providing an uplifting, collaborative work environment and benefits that reflect your value to us. For eligible full-time employees, we offer: - Considerable employer contributions for health, dental, and vision programs - Generous PTO, paid holidays, and paid parental leave - 401(k) matching program - Merit advancement opportunities - Career development & training And finally, our team spirit and culture! We cultivate an environment of community, connection, and belonging across our entire organization. Beyond Finance does not accept unsolicited resumes from individual recruiters or third-party recruiting agencies in response to job positions. No fee will be paid to their parties who submit unsolicited candidates directly to Beyond Finance employees or the Beyond Finance HR team. No placement fee will be paid to any third party unless such a request has been made by the Beyond HR team.
Role Description Azurreo is seeking a QoS Specialist to support service assurance and operational monitoring activities across telecom and technology projects. The successful candidate will be responsible for: - Monitoring operational performance - Managing incidents - Coordinating with stakeholders - Tracking KPIs - Contributing to service quality improvements This position is ideal for candidates with experience in: - Telecom Operations - NOC (Network Operations Center) - Service Assurance - Technical Support - Network Monitoring - IT Operations Candidates without relevant technical or operational experience are unlikely to be successful in this role. Qualifications - Education in one of the following fields: - Telecommunications Engineering - Computer Engineering - Network Engineering - Information Technology - Computer Science - Related Technical Field - Experience in at least one of the following areas: - Telecom Operations - NOC Operations - Service Assurance - QoS Monitoring - Network Monitoring - Technical Support - IT Operations - Preferred technical knowledge of: - TCP/IP Networking - Routing & Switching - Incident Management - Monitoring Tools - Service Assurance Concepts - Telecom Networks - KPI Tracking & Reporting - Professional working proficiency in English (written and spoken) - Ability to communicate effectively with customers and technical teams Requirements - Strong attention to detail - Analytical mindset - Accountability and ownership - Ability to work independently - Strong follow-up and organizational skills Benefits - Competitive Compensation - Fully Remote - Company Equipment - Paid Leave - Training & Development - International Exposure - Career Growth - Overtime Compensation
Fifth Third Bank, National Association is proud to have an engaged and inclusive culture and to promote and ensure equal employment opportunity in all employment decisions regardless of race, color, gender, national origin, religion, age, disability, sexual orientation, gender identity, military status, veteran status or any other legally protected status.
Role Description As a Principal Cyber Threat Analyst on the Detection, Analysis, and Response team, this role is responsible for identifying, investigating, and preventing cyber threats across the enterprise. Unlike a traditional SOC, this team focuses on deep investigations, advanced detection engineering, threat hunting, and rapid response. The ideal candidate brings deep technical expertise in threat detection, incident response, and security operations, combined with a strong understanding of business processes and the financial services landscape. This role partners closely with threat intelligence, engineering, and business stakeholders to proactively identify risk, improve detection and response capabilities, and secure emerging technologies, including AI systems, agentic workflows, and modern development environments such as CI/CD and software supply chains. Success in this role requires initiative, technical depth, and the ability to translate complex threats into actionable outcomes that align with business risk. Key Responsibilities - Analyze alerts, investigate incidents, and lead response activities across enterprise systems, including cloud, endpoint, identity, AI platforms, and CI/CD environments. - Act as Incident Commander and escalation point for high-severity incidents and post-incident reviews. - Perform threat hunting, retro hunting, and deep-dive analysis to identify advanced attack techniques. - Continuously improve detection and response workflows, playbooks, and automation. - Serve as the SME for AI detection and response, including threats such as prompt injection, model abuse, and data leakage. - Partner with business units to understand AI usage and provide guidance on secure implementation and monitoring. - Identify and onboard new telemetry sources for AI platforms and agentic workflows. - Translate emerging AI threats and industry trends into actionable detections and controls. - Provide hands-on mentorship and guidance to analysts during investigations and response efforts. - Set the technical standard for alert review, triage, detection quality, and investigation depth. - Lead by example in incident handling, documentation, and decision-making under pressure. - Support hiring, onboarding, and ongoing development of team members. - Design and maintain detection logic, playbooks, and workflows aligned to threat coverage and business risk. - Ensure detection capabilities support key objectives such as visibility, automation, and data quality. - Identify gaps in tooling, telemetry, and processes; recommend and drive long-term improvements. - Align detection and response strategies with frameworks such as MITRE ATT&CK and emerging AI threat models. - Partner with product owners, engineering teams, and vendors to translate business priorities into security solutions. - Organize and drive cross-functional initiatives to enhance detection and response capabilities and improve overall security maturity. - Support root cause analysis and remediation efforts across technical and business domains. - Communicate risk, threats, and security recommendations effectively to technical and non-technical stakeholders. - Contribute to strategic initiatives and influence security decisions across the organization. - Contribute to detection, analysis, and response for threats targeting CI/CD pipelines and software supply chains. - Improve visibility, telemetry, and detection coverage across the software development lifecycle. - Identify attack patterns and strengthen controls related to build systems, dependencies, and deployment workflows. - Stay current on attacker TTPs, tools, and frameworks, including AI, cloud, and supply chain threats. - Share insights through documentation, training sessions, and team knowledge transfer. - Foster a culture of experimentation, continuous improvement, and technical excellence. Qualifications - Bachelor’s Degree in Computer Science, Information Systems, or other related field, or other relevant experience. - 6 to 8 years of experience with the analysis/investigation and containment of potential data breaches or cyber security incidents. - Scripting/Coding experience - Python, Regex, Yara as examples. - Knowledge of current hacking techniques, vulnerability disclosures, data breach incidents, and security analysis techniques. - Knowledge of malware families, botnets, threats by sector, and various attack campaigns and attacker methods, tools/techniques/practices. - Knowledge of cloud technologies including O365. - Common security controls is required including; authentication, encryption, IDS, WAFs, firewalls, HIPS, EDR, EPP, etc. - Proficient in both Linux and Windows operating systems. - Understanding of application protocols. - Strong analytical, tactical and critical thinking ability. - Ability to handle multiple competing priorities in a fast-paced environment. - Ability to communicate effectively across multiple levels. - Preferred CISSP, GIAC, or other relevant certification. Requirements - Total Base Pay Range: 96,500.00 - 207,500.00 USD Annual. - Eligible to participate in an incentive compensation plan based on company, line of business and/or individual performance. Benefits - Comprehensive benefits programs designed to support the individual needs of employees and their families, encompassing physical, financial, emotional and social well-being. Company Description Fifth Third Bank, National Association is proud to have an engaged and inclusive culture and to promote and ensure equal employment opportunity in all employment decisions regardless of race, color, gender, national origin, religion, age, disability, sexual orientation, gender identity, military status, veteran status or any other legally protected status.
Esta descripción de trabajo ilustra la naturaleza general y el nivel de trabajo realizado por los empleados dentro de esta clasificación de trabajo. No pretende contener ni ser interpretado como un inventario completo de todos los deberes, responsabilidades y habilidades requeridas. La gerencia se reserva el derecho de agregar o modificar deberes en cualquier momento.
Role Description The Cost Savings Specialist plays a critical role in driving customer value by: - Training account managers on best practices for identifying and executing savings. - Creating, validating, and replicating cost savings initiatives across our [Industry Group] Corporate Accounts portfolio. - Collaborating with suppliers to identify needs and engineer industry-specific solutions. - Developing high-impact savings opportunities in partnership with local account managers and suppliers. - Ensuring measurable, documented value consistently flows into the company’s cost savings portal. By strengthening the pipeline of cost savings projects, the Specialist enables Corporate Account Managers (CAMs) and Corporate Account Experience Managers (CAEMs) to deliver compelling value stories to agreement stakeholders — shifting the customer conversation from price to total business impact. Qualifications - Bachelor’s degree; equivalent industry experience. - 5+ years of experience in industrial distribution, supply chain, operations, or related field. - Proven track record of identifying and implementing cost reduction initiatives with measurable results. - Strong analytical and problem-solving abilities. - Excellent communication skills, with the ability to coach internal teams and collaborate with suppliers. - Project management experience, with the ability to lead multiple initiatives simultaneously. - Proficiency in Excel, reporting systems, and data analysis; experience with cost savings portals is a plus. - Willingness to travel. Requirements - Results Oriented: Focused on measurable outcomes that impact both customer and company profitability. - Collaboration: Works effectively with account managers, suppliers, and support staff to drive shared success. - Innovation: Identifies new and creative approaches to delivering savings. - Customer-Centric Mindset: Aligns initiatives to customer goals, reinforcing strategic partnerships. - Scalability: Capable of turning one-off successes into repeatable, industry-wide solutions. Performance Metrics - Annual gross profit dollars generated through cost savings efforts. - Number of validated and documented projects entered in the portal. - Replication rate of successful initiatives across multiple accounts. - Adoption of best practices among account managers. - Customer satisfaction/retention tied to cost savings delivery.
Varonis, established in 2005, is a software company headquartered in New York, New York, specializing in data security and analytics. Its mission is to safeguar
Role Description Varonis is looking for a highly technical, deeply curious Competitive Intelligence Analyst to lead our CI program. Your job is simple to state and hard to do: help Varonis win. You'll research competitors, pressure-test their claims, devise winning plays, and build the tools and automation that let our field self-serve competitive insight at scale. What You'll Own - Deal Support - Provide tailored, proactive support on competitive deals, addressing competitor-specific challenges before they stall an opportunity. - Develop a deep rapport with the field so you're the first call when a competitor shows up in a deal. - Content Creation - Build the tools that win deals: battlecards, playbooks, kill sheets, customer-facing comparisons, and technical positioning, all written to be used, not filed away. - Produce sharp materials with clear points, backed by specific, real examples, not a wall of content or vague positioning. - Competitive Analysis - Run quarterly win/loss analysis with product marketing to understand why we win, why we lose, and how to improve competitive conversion rates. - Connect the dots across functions, feeding deal insight to sales, roadmap input and product gaps to product, and positioning and messaging to marketing. - Competitive News & Questions - Maintain an ongoing pulse on the market, monitoring competitor product updates, announcements, and strategy shifts. - Share timely, sourced analysis with the stakeholders who need it, and build compelling narratives, including win-wires, that the field remembers and repeats. - AI-First Operating Model & CompetiBot Upkeep - Own and continuously improve CompetiBot, our competitive intelligence agent, and the automation behind it, so the field can self-serve accurate, sourced competitive answers at scale. - Design, prompt, and tune agent-based workflows that monitor the market, synthesize intelligence, and surface field-ready guidance, freeing you for higher-order analysis. Qualifications - 5+ years in the cybersecurity market, with a strong focus on data, identity, and cloud security. - 3+ years of relevant experience in one or more of: sales engineering/pre-sales, field-facing competitive intelligence, solutions or technical marketing, product marketing, or product management. - A strong technical foundation and the ability to break down complex systems into actionable insight. - Hands-on comfort with AI agents and automation, or genuine eagerness to learn fast. - Proven ability to simplify complex technical ideas into practical, succinct guidance and executive summaries. - Excellent written, verbal, and visual communication skills, with impeccable attention to detail and experience presenting to executives. - Insatiable curiosity about the cybersecurity market. Requirements - You're technical to the core. - You speak the language of the field, not marketing speak. - You're genuinely excited about AI, not intimidated by it. - You're a skeptic by instinct. - You're a builder with a bias for action. Benefits - One of the most technically respected companies in data security. - A role where your job is to help the company win, with visibility across sales, product, and marketing. - A company investing seriously in AI across the go-to-market function. - Competitive compensation, equity, and a culture that values ownership and impact. Company Description This position is remote with occasional travel to Varonis HQ in New York City and to corporate tradeshows. Regular remote collaboration with colleagues in Israel is required. Varonis is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics.
We help incredible people find an amazing job working from home for a United States based business.
Role Description At Job Duck, we are looking for a dynamic and client-focused Intake Specialist who thrives in a fast-paced legal environment and takes pride in creating a welcoming first impression for clients. In this role, you will be the primary point of contact, guiding prospective clients through the intake process with professionalism, empathy, and clarity. You will play a key role in supporting case flow by managing communications, scheduling, and administrative tasks that directly impact client satisfaction and firm efficiency. The ideal candidate is naturally personable, detail-oriented, and proactive, with a strong ability to multitask while maintaining a warm and approachable demeanor. If you enjoy meaningful client interaction and contributing to a smooth and organized workflow, this is an exciting opportunity to grow your career. - Compensation Range: 1142 USD to 1220 USD Responsibilities include, but are not limited to: - Post content on social media on a weekly basis - Perform conflict checks before onboarding new clients - Draft and send engagement letters - Schedule consultations and manage calendars - Answer incoming phone calls and provide a welcoming and professional first impression - Support overall administrative operations to ensure smooth client experience - Open and maintain client files accurately - Assist with billing-related processes - Conduct client intake and gather necessary case information Qualifications - Schedule: 4-day work week, Monday through Thursday - Working hours: 8:00 a.m. to 5:00 p.m. CST - Location: Remote - Industry: Legal services (Family Law) Requirements - CRM: Clio - VOIP: Zoom Phone - Microsoft 365 - Candidates must be comfortable handling client-facing responsibilities and administrative workflows in a legal setting Benefits - Work Shift: 8:00 AM - 5:00 PM [CST][CDT] (United States of America) - Languages: English, Spanish Company Description For ambitious, culturally diverse, curious minds seeking booming careers, Job Duck unlocks and nurtures your potential. We connect you with rewarding, remote job opportunities with US-based employers who recognize and appreciate your skills, allowing you to not just survive but thrive. As a lifestyle company, we ensure that everybody working here has a fantastic time, which is why we’ve earned the Great Place to Work Certification every year since 2022!
Founded in 2002, Infinity Ward is the original studio behind the Call of Duty® franchise. The titles developed by Infinity Ward have won more than 200 "Game of the Year" awards and 100 "Editor's Choice" awards, among many other industry accolades. Some of our previous titles include: Call of Duty®: Ghosts, Call of Duty®: Infinite Warfare and most recently, Call of Duty®: Modern Warfare II. A critically acclaimed studio, Infinity Ward is proud to have one of the most passionate and talented development teams in the industry. We love to have as much fun as the games we create, and it shows in our relaxed, yet diligent, workplace environment. We believe that making the best games relies on having the best people, so we like to look after ours. We enjoy having fun with top-notch events that everyone gets involved with. Infinity Ward is wholly owned by Activision. To learn more about our studio, please visit us at infinityward.com , on Facebook at Facebook , and @InfinityWard on Twitter.
Role Description Are you passionate about being a part of a high performing global team that values collaboration, process excellence and innovation? Do you want to impact the Purchase to Pay industry and the direction of Purchase to Pay within Microsoft/ABK? The vision for ABK Purchase to Pay (P2P) at Microsoft is to provide frictionless end to end payment and calculation solutions that seek to reduce user time, allow our operations to scale, and move beyond being a cost center for the company. ABK P2P team manages approximately $3B of supplier payments annually. P2P operations are outsourced as managed service and the environment is rapidly transforming and expanding. The Senior P2P Engagement & Governance Specialist is responsible for end-end P2P operations within their functional area of expertise, ensuring best practices apply. This role requires engagement with Sr. stakeholders, Finance, Compliance, Procurement, Treasury and our Business Process Outsource partner. The optimal candidate should demonstrate: - Excellent communication skills - Thought-leadership capability - Knowledge of industry best practices - Ability to identify areas of improvement - Proactively implement and lead change initiatives - Strong collaboration skills - Ability to influence others - Proven working experience in managing complex P2P and Accounts Payable processes in a fast-paced business environment Priorities can often change in a fast-paced environment like ours, so this role includes, but is not limited to, the following responsibilities: - Govern outsourced P2P operations by monitoring KPIs, SLAs, and service delivery performance to ensure accountability and operational excellence - Drive continuous improvement initiatives by identifying process inefficiencies, conducting root cause analysis, and implementing scalable solutions - Partner with Finance, Procurement, Treasury, Compliance, and business stakeholders to ensure alignment of P2P operations with enterprise objectives - Build and maintain strong controls environments while ensuring adherence to policies, procedures, and audit requirements - Influence cross-functional partners and managed service providers to deliver against agreed operational outcomes without direct authority - Develop and deliver training programs to business groups to improve understanding and adoption of P2P processes - Monitor system performance and communication channels to ensure smooth end-to-end invoice and payment processing - Lead or contribute to cross-functional process improvement initiatives and transformation projects Qualifications - 4+ years of experience in business operations, finance operations, process management, program management, or process improvement - Experience working within a Purchase-to-Pay (P2P) and/or Accounts Payable environment - Proven experience managing or partnering with outsourced service providers or managed services - Demonstrated experience in process improvement, operational governance, or workflow design - Bachelor’s degree in Business, Finance, or related field (or equivalent experience) - Strong understanding of end-to-end P2P / AP processes and operational controls - Proficiency in PowerPoint and ability to develop executive-level presentations - Experience with data-driven decision-making and cross-functional communication Requirements - Strong communicator with ability to influence across all levels of the organization - Comfortable working in ambiguous, fast-changing environments - Strong problem solver with ability to balance detail orientation and big-picture thinking - Highly collaborative with strong stakeholder management skills Extra Points - Experience leading or supporting large-scale process transformation or global operational programs - Experience working in complex, multi-stakeholder enterprise environments - Prior experience in gaming, tech, or global entertainment companies - Six Sigma certification or formal process improvement training - Familiarity with ERP systems and P2P tools/platforms - Project management certification or formal project delivery experience - Strong bias toward operational excellence and continuous improvement - Proven ability to build trust and drive alignment across diverse stakeholders Benefits - Medical, dental, vision, health savings account or health reimbursement account, healthcare spending accounts, dependent care spending accounts, life and AD&D insurance, disability insurance - 401(k) with Company match, tuition reimbursement, charitable donation matching - Paid holidays and vacation, paid sick time, floating holidays, compassion and bereavement leaves, parental leave - Mental health & wellbeing programs, fitness programs, free and discounted games, and a variety of other voluntary benefit programs like supplemental life & disability, legal service, ID protection, rental insurance, and others - Relocation assistance may be available if required to move geographic locations for the job
The World Leader In Serving Science
Role Description Join Us as a Sr. Country Approval Specialist/Principal Country Approval Specialist and make an impact at the forefront of innovation. The Sr. Country Approval Specialist/Principal Country Approval Specialist manages the preparation, review, and coordination of Country Submissions in line with global submission strategy. - Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. - Provide local regulatory strategy advice (MoH &/or EC) to internal clients. - Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments. - Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner. - Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner. - Act as a key-contact at country level for all submission-related activities. - Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings. - Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation. - Achieve company’s target cycle times for site activations. - Prepare the regulatory compliance review packages, as applicable. - Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy. - Develop country specific Patient Information Sheet/Informed Consent form documents. - May assist with grant budgets(s) and payment schedules negotiations with sites. - Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions. - Support the coordination of feasibility activities, as required, in accordance with agreed timelines. - Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times. - Oversee country study files and ensure that they meet PPD WPD’s or client SOP’s. - Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. - Direct/mentor other SIA individuals assigned to support projects of responsibility, as appropriate. - Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate. Qualifications - Bachelor's degree or equivalent and relevant formal academic/vocational qualification. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5+ years). - In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Requirements - Effective oral and written communication skills. - Excellent interpersonal skills. - Strong attention to detail and quality of documentation. - Good negotiation skills. - Good computer skills and the ability to learn appropriate software. - Good English language and grammar skills. - Good judgment and decision-making skills. - Basic medical/therapeutic area and medical terminology knowledge. - Ability to work in a team environment or independently, with minimal supervision, as required. - Ability to mentor fellow SIA team members in a positive and effective manner. - Excellent team player with teambuilding skills. - Basic organizational and planning skills. - Excellent knowledge of all applicable regional/national country regulatory guidelines and EC regulations. Working Conditions and Environment - Fully work from home position. Benefits - When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. - You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
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