Allucent

Accountant

• Ensure that all the vouchers are recorded, to arrange the supporting documents and name the file accordingly and save the documents in the shared folder and attached the supporting documents to the vouchers and to ensure to close the books monthly accurately.
• To create monthly Inter -Co Invoices relating to PT and Management invoices within the stipulated time.
• To check diligently all the documents/invoices/receipts related to the vouchers for applicable TDS and to ensure the TDS are deducted and arrange for timely payment to the vendors and employee’s reimbursement on time.
• Check all the expense reports in Dynamics submitted by the employee towards PT and non-PT claims, and ensure that the supporting documents are correct, and approved on time.
• Reconciliation of HDFC bank account day to day basis and check to ensure the required funds are available in the bank account. Invest the surplus money with HDFC bank effectively.
• Closely monitor the bank/cash position and plan the disbursements accordingly. Prepare the weekly cash forecast for disbursements and actuals and send to the global treasurer/designated person and always keep a good cash position.
• Preparation /Filing of timely all statutory returns like TDS, GST, EPF, PT, Statutory Bonus, ER- 1 to Employment Exchange, Form -U under Labour Department, POSH, ESIC etc. within the stipulated timeline provided by varies departments.
• To work closely with the company Auditors and assist to complete the Statutory Audit, Tax Gratuity and Corporate Secretarial compliances as per requirements.
• General and Office Insurance Policy, to ensure that new assets are added to the office insurance policy and arrange to get the claim for any damages if applicable and to provide the list of assets for the renewal of office policy.
• Ensure to collect all the required data from new joinees and left employees & enrol them under Payroll, EPF , Gratuity etc., as applicable within the stipulated time.
• Payroll Processing – GreytHR -to ensure that all new employees are added in payroll in each month, and update all their data, tax computation and ensure that the salary paid in time with all applicable deductions and also work on final settlement of left employees and paid as required from HR
• Ensure to release the Income tax declaration & Proof of investment forms as & when required and effect the correct tax for all employee and file the return and issue the Statutory tax form 16 within the stipulated time.
• To ensure to generate Quarterly e-filing of TDS and generate TDS forms as per requirement and annual requirements.
• Provide information or reports as requested by Global finance team members.
• Liaise with all levels within the organization
• Any other projects as assigned.

Manager, Accountant

Financial Planning and Analysis

• *At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• Allucent (India) Pvt. Ltd. is seeking for Manager for the Project Financial Analysis Organization (MPFA) is responsible for managing and leading the Project Financial Analysis activities within the financial function of Allucent. The MPFA ensures planning, preparation and execution of Project Financial Analysis in accordance with the standard operating procedures, regulatory guidelines, executed client contract and the clients’ expectations. The MPFA is a member of the Director of Project Financial Analysis’ team.
• **In this role your key tasks will include:**
• - Contribute to the identification, development and implementation of the business strategy for the Project Financial Analysis.
• - Contribute to development of annual revenues, sales, profit and operational targets for the Project Financial Analysis.
• - Evaluate and contribute to the development of the area strategy and tactics planning.
• - Develop and agree upon operating procedures / business processes.
• - Manage direct reporting staff.
• - Ensure the availability of required capable resources for the area.
• - Collaborate and ensure open communication with other areas.
• - Report to the leaderships team.
• - Ensure activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care
• - Partner with project teams to create budgets and forecasting timelines for multiple projects and sponsors with focus on project profitability and hours spend analysis at task and resource level
• - Functional management of project analysts including mentoring, training, performance management, and performance review of team of analysts
• - Monthly review of portfolio of projects for revenue, forecasting, and backlog to ensure proper revenue recognition and support provided in a 606 Accounting Structure
• - Provides adhoc analysis as requested by senior management necessary to assist in the management of the region(s), Client(s)
• - Manage sponsor invoicing and cash collection for portfolio of studies to ensure Allucent is obtaining quarterly cash collection goals.
• - Provides additional support for specialty tasks to the business including Sponsor invoicing system updates, forecasting, and revenue recognition integration.
• - Oversee invoicing of sponsors per signed budget and contract
• - Develop quality analysis of projects by measuring budget vs. actual
• - Analyze and implement new development plans and actively participate in the Director team (strategy – leadership – business integration) meetings to identify and implement new area related goals and strategies.
• - Manage direct reporting staff.
• - Actively contribute to staff learning & development within the company.
• - Provide and coordinate Project Financial Analysis training for relevant staff.
• - Review, improve and evaluate Project Financial Analysis processes and procedures within the Quality Management System.
• - Assure strong long-lasting relationships with (future) key accounts.
• - Support in preparation of new proposals.
• - Contribute and take part in client evaluations, visits and bid defense.

Manager, Project Financial Analysis

Software Engineer

• Design, build, test and release clinical databases to the production environment.
• Develop and maintain all clinical programming documentations in support of implementation and ongoing data management activities.
• Review and provide input to study documentation including Data Validation Plan, UAT Plan, test cases and eCRF completion guidelines.
• Program electronic edit checks and data listings required for data review and validation process.
• Develop and/or validate SAS programs for metric reporting, data import, data reconciliation and data export set-up.
• Lead and support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH, TAUGs and SDTM models.
• Review, input and adhere to the requirements of study-specific data management documents & plans.
• Develop, lead and coordinate clinical programming activities for assigned studies (including monitoring of project timelines, scope of work, budgets, resourcing needs, escalating potential problems effectively and in a timely manner and alerting management of potential change orders).
• Participates in/contributes to/leads study team meetings and departmental meetings, uses analytical approach to providing input and problem solving.
• Collaborates with peers and study teams to clarify specifications and uses expanded technical skills to meet evolving project needs.
• Provides leadership, guidance and support to junior programmers and other department members.
• Understands and promotes validation principles and consistently develops code in accordance with those requirements.
• Defines and promotes clinical programming best practices, training materials, global libraries and standard documents.
• Lead development activities in standardizing clinical programming procedures (e.g. setting up global libraries, standard templates).
• Maintain a broad overall knowledge in the field of clinical programming and clinical data management by reading literature, self-training, continuous professional development, attending training classes and professional meetings etc.
• Research, propose and lead process improvement initiatives.
• Actively support staff learning & development within the company.
• Share relevant information at applicable team/department meetings.
• Develops and delivers applicable departmental trainings.
• Train and mentor data management and clinical programming staff.
• Participate in the interview process for new recruits.
• Represent the company at professional meetings, webinars, seminars or through blogs and publications.
• Draft and contribute as Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes and procedures within the Quality Management System.
• Assure good communication and relationships with (future) clients.
• Contribute and take part in client evaluations, visits and bid defenses.
• Support in preparation of new proposal.

Senior Clinical Programmer

SDET

• We are looking for a detail-oriented and experienced Senior Software Tester with 5–8 years of hands-on experience in software quality assurance and test automation.** The candidate will play a crucial role in ensuring the reliability, performance, and scalability of applications developed within Country Intelligence, Site Intelligence, and ALLuminosity initiatives.** This role involves manual and automated testing of web applications built on Node.js, Java Spring Boot, Python/PySpark, Azure SQL, Databricks with a focus on validating RESTful APIs and data pipelines, debugging issues, and collaborating closely with developers and business teams to deliver defect-free solutions.

Test Engineer

Director

• Shape the future of drug development as our next Director of Pharmacometrics.
• Lead multiple projects, guide teams, and stay hands-on with PK and PK/PD analyses using tools like NONMEM and R.
• Oversee multiple projects, serving as the senior technical modeler and project lead.
• Collaborate closely with cross-functional teams to design, execute, and interpret population PK and PK/PD models.
• Mentor a talented team of pharmacometricians, helping them grow technically and strategically.

Director, Pharmacometrics

• Shape the future of drug development as our next Director of Pharmacometrics
• Lead multiple projects, guide teams, and stay hands-on with PK and PK/PD analyses using tools like NONMEM and R
• Oversee multiple projects, serving as the senior technical modeler and project lead
• Collaborate closely with cross-functional teams to design, execute, and interpret population PK and PK/PD models that influence regulatory and clinical outcomes
• Mentor a talented team of pharmacometricians, helping them grow technically and strategically while fostering a culture of curiosity and excellence

• Lead multiple projects as the senior technical modeler and project lead
• Oversee strategy, guiding analysis, and driving decisions for programs
• Collaborate closely with cross-functional teams to design, execute, and interpret population PK and PK/PD models
• Mentor a talented team of pharmacometricians, fostering a culture of curiosity and excellence

• Shape the future of drug development as Director of Pharmacometrics
• Lead multiple projects, guide teams, and stay hands-on with PK and PK/PD analyses
• Oversee multiple projects, serving as senior technical modeler and project lead
• Collaborate closely with cross-functional teams to design, execute, and interpret models
• Mentor a talented team of pharmacometricians

Clinical Operations

• **Your main responsibilities will include but not limited to: **
• - Driving project success by leading cross-functional teams to deliver clinical trials on time, within scope, and on budget.
• - Ensuring excellence and compliance by developing and executing project plans aligned with GCP, SOPs, and regulatory standards.
• - Aligning stakeholders by serving as the primary point of contact for sponsors, vendors, and internal teams.
• - Optimizing vendor performance through strategic selection, management, and oversight.
• - Mitigating risks and control budgets by proactively addressing challenges, scope changes, and resource allocation.
• - Maintaining inspection-ready documentation by leading key meetings and ensuring the Trial Master File and study records are complete.

Senior Clinical Project Manager

Operations

• **Your main responsibilities will include but not limited to:**
• - Lead the design, accuracy, and optimization of Salesforce (SFDC) to ensure data integrity and alignment with business needs.
• - Develop and deliver executive-level reporting, including weekly summaries, MBRs, BOD decks, and ad hoc business analyses.
• - Partner with Operations to analyze business performance, identify variances, assess root causes, and recommend corrective actions.
• - Support financial forecasting and budgeting for the company and business units, providing insights that guide strategic decisions.
• - Oversee opportunity and contract reporting, ensuring all WOs, change orders, and related data are tracked and reported accurately.
• - Mentor and guide analysts and SFDC administrators, fostering learning, collaboration, and continuous improvement across the team.

Director, Sales Operations

• Develop and oversee administration of internal metrics across Shared Services.
• Utilize metrics to influence efficiencies across internal teams and business partners.
• Identify and develop Shared Services priorities, driving an environment of continuous improvement.
• Lead Projects/Initiatives across the shared Services organization.
• Define and agree SLAs with “in scope” entities, including KPIs, and manage performance.
• Lead financial shared services team of approximately 30 employees in two locations in India.
• Procure to Pay (Accounts Payable, Travel & Expense Reporting, Credit Card administration, Payment Execution). Order to Cash (Invoicing, Credit Management, Collections, Payment Application, Credit Note Processing).
• Maintain environment of continuous improvement in financial shared services.

Director, Accounting and Finance

Research Analyst

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Mentor and support junior CRAs, sharing knowledge and best practices.

Clinical Research Associate II – Senior Clinical Research Associate

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Activities around regulatory affairs, site activation and study-startup.

Clinical Research Associate II

Business Development Rep

• Generate and qualify new business leads and set up meetings with potential clients.
• Collaborate with Business Development colleagues to build and execute strategic territory plans.
• Research potential clients using tools such as GlobalData, Zymewire, LinkedIn Navigator, and ZoomInfo.
• Develop and deliver targeted outreach campaigns and messaging to prospective clients.
• Manage the early stages of the sales process by identifying client needs and introducing Allucent’s service offerings.
• Coordinate with Marketing to support conferences, events, and promotional activities.
• Track and report outreach activity in Salesforce, providing insights to drive improvement.
• Support preparation for client meetings.
• Contribute to continuous improvement in Business Development processes and quality systems.

Senior Account Development Manager – Europe

• Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions
• Provide statistical consulting for complex and/or novel statistical analyses
• Provide statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams
• Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable
• Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study
• Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity
• Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
• Interpret and communicate results for complex statistical analyses and outputs
• Develop and/or review the statistical sections of a study protocol for studies of any complexity level
• Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses
• Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications
• Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports
• Working knowledge of SAS® for production and validation of datasets and statistical outputs
• Write and review specifications for complex ADaM or analysis datasets · Annotate or review annotations of TLF mocks to assist programming efforts
• Working knowledge of CDISC standards
• Review CRF design to ensure it conforms with the study protocol and analysis needs
• Review data management documents as requested to ensure integrity of study data
• Lead highly complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing
• Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings
• Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value
• Identify high-risk or high-impact deliverables and assign appropriate oversight
• Lead and manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process
• Collaborate with and verify open communication with other functional areas and business units
• Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams
• Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients
• Provide key input into project proposals and budgets
• Establish positive relationships with current and future clients
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
• Monitor and assure client satisfaction on existing projects for biostatistics and statistical programming
• Contribute to BIOSC, BBU, and corporate marketing activities via blogs, webinars, white papers, and other publications and presentations
• Contribute to other areas of business and assignments as required

Director / Senior Director, Biostatistical Consulting

Medical Director

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• We are looking for a Medical Director to join our A-team (office-based*/remote). The Medical Director works independently to ensure the medical/clinical and safety integrity and quality of trials conducted by Allucent. Serves as the medical monitor contact in trial protocols to investigators and trial sites regarding protocol related questions and safety of the subjects enrolled. Advises investigators, project teams, and clients on safety issues arising from medicinal products, devices and trial designs undertaken by Allucent. Works along with more senior colleagues and internal team members, senior management and business development on issues and questions of any medical /clinical nature. Reviews SAEs, SUSARs and AEs reports and writes safety narratives in accordance with all applicable competent authority regulations and reporting standards. Reviews, if needed with support from more senior colleagues, protocols, investigator’s brochures, clinical trial reports written by Allucent ensuring they are approved in accordance with Allucent procedures and good medical practices. Supports Business Development efforts with support of senior colleagues by reviewing the proposal and attending client meetings including Bid Pursuit Meetings.
• Key tasks: Independently provide medical monitor support to assigned clinical trials; Provide input on Protocol design and Strategic clinical recommendations; Prepare Medical Monitoring and relevant plans; Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events; Assist clinical data management with MedDRA and WHO coding; Review clinical trial documents for medical consistency; Assist in set up and conduct of Data Safety Boards and Dose escalation meetings; Attend and present in Kick-Off, Investigators’ meeting; Provide 24/7 urgent medical support; Training of project teams; Support protocol deviation guidance; Identify trial risks and provide input to Risk plan; Ensure conduct of safety reviews; Independently review and understand trial medical deliverables and track budget; Draft and contribute as SME to evaluation/improvement of processes; Support Business Development; May advise and assist clients on product development and trial designs; May provide therapeutic consultation for post marketing activities; Assure strong relationships with key accounts; Support in preparation of new proposals; Contribute to client evaluations and bid defense; Contribute to other areas of business as required.

Associate Medical Director / Medical Director

• Provide work instruction and support to the shared services organization (finance and accounting, credit and collections, accounts payable, investigator payments, payroll, project finance, travel & expense, credit card administration, and treasury support)
• Ensure timely and accurate processing of accounting transactions and compliance with policies and procedures
• Maintain an environment of continuous improvement and accurate reporting
• Develop and oversee administration of internal metrics across accounting and finance functions
• Utilize metrics to influence efficiencies across internal teams and business partners
• Identify and develop priorities to drive continuous improvement
• Lead projects/initiatives across the finance organization
• Define and agree SLAs with in-scope entities, including KPIs, and manage performance
• Manage Procure-to-Pay (Accounts Payable, Travel & Expense, Credit Card administration, Payment Execution) and Order-to-Cash (Invoicing, Credit Management, Collections, Payment Application, Credit Note Processing)
• Provide and coordinate finance training for relevant staff and operations teams
• Actively contribute to staff learning & development and provide process training
• Identify issues, propose solutions, coordinate with stakeholders, and see to completion
• Adhere to accounting standards and ensure client satisfaction and internal financial accuracy

Finance Manager

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• We are looking for Project Financial Analyst Associate to join our A-team (hybrid). The Project Financial Analyst Associate (PFAA) assists the Project Financial Analyst (PFA) and Project Team with financial activities on the studies that we conduct for our sponsor and includes activities from project start-up to project close-out. This position regularly interacts with the PFA and Project Management to support project requirements.
• Upon contract signature, the PFAA works with the Project Team, PFA, and the proposal function to ensure that the project is set up in Microsoft Dynamics, including the WBS for time keeping, project budgets, and payment schedule details, ensuring all are tied out to the fully executed contract.
• For any subsequent agreements (i.e. Change Order), the PFAA will ensure all respective updates are made in Microsoft Dynamics and tie to the latest fully executed agreement.
• The PFAA will be responsible for assisting in the initiation of any upfront advance requests with the Invoicing Department upon contract signature.
• The PFAA will manage time movement requests for T&M projects in Microsoft Dynamics.
• For T&M studies, the PFAA will distribute financial reports to the project teams, including realization, profitability, budget vs actual, and confirm if a Change Order is needed.
• Upon Project Completion, PFAA will update Microsoft Dynamics, including study status, provide summary of final financial reporting to the PFA and Project Team, and assist the PFA in final reconciliations of invoicing.
• Good knowledge and hands-on experience handling monthly financial reports and closely working with Billing team to ensure smooth invoicing process.
• Knowledge of month-on-month revenue recognition process.
• PFA to Assist in updating journals on agreed timeline and ensuring Invoice is accurately sent out.
• Ensure financial information is complete accurately as per the monthly calendar and reporting to ensure month end close activities.
• Read and understand the contract to help ensure adherence to project scope and contractual deliverables.
• Provide financial support and work with PFA and study teams to implement corrective actions and process improvements.
• Actively contribute to staff learning & development within the company.
• Monitor and assure client satisfaction on finance related activities.

Project Financial Analyst, Associate

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Activities around regulatory affairs, site activation and study-startup.
• Travel throughout The UK.

Senior Clinical Research Associate

System Administrator

• Serve as the primary administrator for the Microsoft Dynamics 365 F&O platform, ensuring optimal system performance, security, and availability.
• Manage user access, security roles, and permissions in compliance with internal controls, segregation of duties, and audit requirements.
• Monitor and maintain system performance, scheduled batch jobs, and key operational processes to ensure uninterrupted financial operations.
• Configure, customize, and deploy forms, views, workflows, and packages to meet evolving business and compliance requirements.
• Lead and support data-related activities, including imports, validations, reconciliations, and data integrity initiatives using D365 data management tools and Excel add-ins.
• Troubleshoot and resolve complex functional and technical issues, collaborating with internal IT teams and external vendors to implement long-term solutions.
• Manage and support system integrations (e.g., payroll, expense, banking, reporting tools) by monitoring data flows, resolving integration errors, and optimizing integration performance.
• Plan, coordinate, and execute user acceptance testing, patch validations, and production release rollouts, ensuring minimal disruption to business operations.
• Maintain and enhance a comprehensive knowledge base, including process documentation, configuration records, and troubleshooting guides.
• Collaborate closely with finance leadership, business process owners, and IT teams to align system capabilities with organizational needs and regulatory requirements.
• Stay current on Microsoft D365 Finance updates, roadmap items, and new functionality, proactively assessing their potential impact and value to the organization.
• Identify, recommend, and implement process and system improvements to enhance efficiency, data quality, and user experience.
• Support and maintain Power BI and other business intelligence platforms to ensure reliable reporting and analytics delivery.
• Partner with finance and operations teams to design, develop, and optimize dashboards, reports, and analytics strategies that drive data-informed decision-making.
• Contribute to the development and maintenance of a centralized data lake and reporting framework to enable enterprise-wide analytics capabilities.
• Ensure the stability, availability, and performance of reporting environments in coordination with operational and technical teams.

Systems Administrator, Corporate Applications

Vice President

• Lead Regulatory Writing & Strategy: Write, review, and guide CMC documents and submissions with accuracy and insight.
• Shape Product Development: Influence strategies and plans from early development through post-approval.
• Engage with Health Authorities: Lead meetings, prepare briefing packages, and serve as the expert voice in regulatory interactions.
• Provide Scientific Leadership: Share expertise in CMC, compliance, and audits while mentoring teams and supporting client success.
• Drive Collaboration & Solutions: Partner with clients and cross-functional teams to solve challenges and deliver innovative outcomes.

VP, Chemistry, Manufacturing and Controls – CMC

Compliance

• Step into a leadership role guiding clients through the complexities of drug, biologic, and medical device development—leading teams, shaping strategies, and ensuring successful submissions.
• You’ll be the trusted expert who turns regulations into real-world impact on global healthcare.
• Lead and mentor regulatory teams; shape strategies; ensure the delivery of high-quality, scientifically sound submissions.
• Serve as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
• Review and author regulatory and scientific documents while driving successful outcomes for clients.
• Act as a trusted expert in Health Authority (HA) interactions and translate regulatory requirements into clear, actionable plans. In this role, you will act as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
• Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
• Reviews and prepares HA meeting requests and briefing documents.
• Provide specialized CMC regulatory expertise across both pre-and post marketing strategies.
• Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
• Evaluates change impact and necessary HA reporting requirements and strategies for drug products or devices from development through post-approval management.
• Has advanced knowledge of CTD format and structure for regulatory submissions.

Manager, Accountant

Manager, Project Financial Analysis

Senior Clinical Programmer

Test Engineer

Director, Pharmacometrics

Director, Pharmacometrics

Director, Pharmacometrics

Director, Pharmacometrics

Senior Clinical Project Manager

Director, Sales Operations

Director, Accounting and Finance

Clinical Research Associate II – Senior Clinical Research Associate

Clinical Research Associate II

Senior Account Development Manager – Europe

Director / Senior Director, Biostatistical Consulting

Associate Medical Director / Medical Director

Finance Manager

Project Financial Analyst, Associate

Senior Clinical Research Associate

Systems Administrator, Corporate Applications

VP, Chemistry, Manufacturing and Controls – CMC

Associate Director, Regulatory Affairs