Parexel

Compliance

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Regulatory Affairs Consultant – CMC Biologics

• Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs
• Prepare and review CMC packages
• Support GMP submissions
• Manage change control assessments
• Ensure compliance with regulatory requirements across multiple regions
• Act as the main GRA point of contact for LRAs and other stakeholders
• Author Administrative and CMC regulatory documents/deliverables
• Collaborate with project SMEs and client stakeholders to prepare submission packages

Regulatory Affairs Consultant – CMC, Biological, Vaccines

Medical Director

• Initiate and maintain medical and consultative relationships with clients
• Consult on early engagement and pre-award efforts
• Serve as a medical monitor for contracted projects
• Independently deliver all medical support required for successful delivery of the projects
• Provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings

Medical Director – Ophthalmology

Research Analyst

• Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
• Build relationships with investigators and site staff.
• Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
• Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
• Follow-up on and respond to appropriate site related questions.
• Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
• Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
• Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Ensure timely and accurate completion of project goals and update of applicable trial management systems.

Clinical Research Associate II

Data Analyst

• Create and maintain standardized data visualizations.
• Apply visualization standards aligned with RBQM and CtQ endpoints.
• Implement visual analytics within study timelines.
• Support documentation and quality control.
• Participate in training and incorporate feedback.
• Assist with stakeholder requests.
• Apply independent judgment in prioritization and decision-making.
• Address moderately complex statistical or data issues.
• Participate in peer review and mentoring.

Real-time Visual Analytics Specialist

Data Scientist

• Data Management POC for studies in which we are included in
• Responsible for mapping local study dictionaries to CDISC Standards
• Participate and contribute to the development of operational plans to ensure data quality and completeness
• Develop, Implement, and Conduct data quality checks as needed for work/studies
• Work closely with the various stakeholders to understand evolving project portfolio needs, and integration into the systems and requirements; supporting studies with a wide range of disease domains
• Contribute technical expertise toward the design, implementation, and scaling up of sensor systems and analytics
• As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from lab, asset teams, and external collaboration studies is consistent with 21CFR part 11
• Contribute to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements
• Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
• Manage own time to meet agreed targets
• Work under general supervision. Performs assignments using established procedures and general instruction
• Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications

Clinical Data Manager – Digital Medicine and Translational Imaging

• Initiate and maintain medical and consultative relationships with clients
• Serve as a medical monitor for contracted projects
• Deliver all medical support required for successful project delivery
• Provide medical expertise and leadership in Proposal Development Teams
• Collaborate on internal therapeutic area meetings, training module development, and publications

• Initiate and maintain medical and consultative relationships with clients
• Consult on early engagement and pre-award efforts
• Serve as a medical monitor for contracted projects
• Provide medical expertise / leadership in Proposal Development Teams for client bid pursuit meetings

Director

• Join our dynamic Patient Safety team as a Medical Safety Director where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and post-marketing settings.
• Perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects.
• Mentor junior team members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance.
• Collaborate with cross-functional teams, interact with clients, and contribute to the continuous improvement of our pharmacovigilance processes.

Medical Safety Director

• Initiate and maintain medical and consultative relationships with clients
• Serve as a medical monitor for contracted projects
• Independently deliver all medical support required for successful delivery of the projects
• Provide medical expertise/leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings
• Collaborate on internal therapeutic area meetings, training module development, white papers, publications etc.

Manager

• Responsible for mapping local study dictionaries sponsor standards
• Participate and contribute to the development of operational plans to ensure data quality and completeness
• Develop, Implement, and Conduct data quality checks as needed for work/studies
• Work closely with the various stakeholders to understand evolving project portfolio needs, and integration into the systems and requirements; supporting studies with a wide range of disease domains.
• Contribute technical expertise toward the design, implementation, and scaling up of sensor systems and analytics
• Ensure collection, organization, curation, storage and safeguarding of patient data
• Contribute to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements
• Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
• Manage own time to meet agreed targets
• Work under general supervision. Performs assignments using established procedures and general instruction
• Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.

Medical Informatics Manager – Digital Medicine Study Manager

Conversion Rate Optimizer

• Amend, negotiate and finalize project budgets
• Support change in scopes and work on contract development
• Prepare and finalize draft contract documents
• May negotiate budget changes with clients
• Direct client interaction with established contacts
• Provide quality client deliverables to strict deadlines
• Facilitate review and approval of contractual documents and budgets
• Participate in contract review meetings with clients and internal customers

CRO Pricing & Contracts Specialist

Risk

• Works with the quality governance chairs and coordinators to lead and execute quality governance forums addressing quality concerns and risk adjudication and escalation.
• Plans, drafts, reviews and delivers outputs from quality governance forums including escalations, decisions, annual reports and other documentation as well as coordinate, prioritize and sequence quality governance topics.
• Directs GCP quality governance metrics and assessment of GCP quality governance effectiveness and efficiency.
• Collects and reports data to support assessment of compliance to process, trends, and common issues with a view towards overall impact and continuous improvement.
• Serves as liaison between GCP quality governance board members and teams providing clear communication and direction on goals and objectives for review completion.
• Execution and oversight of the periodic review of GCP quality governance forum remit, charter, scope, membership.
• Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training.

GCP Quality Governance Operations Lead – Senior Manager

• Provide medical monitoring for assigned projects
• Function as medical representative on the project team
• Provide medical consultation as required or requested to client/sponsor or to other Parexel service groups
• Review all individual adverse experience reports for accuracy and clinical importance
• Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis
• Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data
• Review documents written by various Parexel divisions for safety issues
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and journal articles

Medical Director, Oncology – GI Subspecialty

• Works with the quality governance chairs and coordinators to lead and execute quality governance forums addressing quality concerns and risk adjudication and escalation.
• Plans, drafts, reviews and delivers outputs from quality governance forums including escalations, decisions, annual reports and other documentation as well as coordinate, prioritize and sequence quality governance topics.
• Directs GCP quality governance metrics and assessment of GCP quality governance effectiveness and efficiency. Collects and reports data to support assessment of compliance to process, trends, and common issues with a view towards overall impact and continuous improvement
• Serves as liaison between GCP quality governance board members and teams providing clear communication and direction on goals and objectives for review completion.
• Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training