Job Opportunities at PAREXEL

KEY ACCOUNTABILITIES:

Project Execution: Medical Monitoring Delivery & PV Support

• Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician)
• Participate actively in study planning with feasibility leaders, solution consultants
• Participate in team project and investigator meetings
• Provide training of study teams on TA indication and protocol (Note that this does not include any direct medical advice on patient care or management)
• Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study
• Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients/sponsors or in conjunction with other Parexel departments
• Deliver medical monitoring activities according to MMP during the study conduct
• Deliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned either GLP or RLP
• Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events

Client Relationship Building & Engagement

• Support Business Development
• Provide medical expertise to client across multiple channels and interactions
• Consultancy on protocol development or drug development program
• Medical review of various documents, which might be audited by clients and regulatory agencies
• Provide medical expertise and training to other Parexel colleagues​​

KNOWLEDGE & EXPERIENCE:

• Must have completed gastroenterology specialty training to be considered for the role.
• Clinical and/or research experience in MASH (metabolic associated liver disease) and/or IBD
• A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution preferred.
• Clinical practice experience
• Good knowledge of the drug development process including drug safety, preferred
• Experience in Pharmaceutical Medicine, preferred
• Experience leading, mentoring and managing individuals/ a team, preferred
• Excellent English language skills

EDUCATION:

• Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine

SKILLS:

• Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
• Client-focused approach to work
• Excellent time management skills
• Excellent verbal and written medical communication skills
• Excellent standard of written and spoken English
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork

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Key Deliverables in the role:

• Manage the local submissions (as Local Regulatory Contact - LRC)
• Coordinate the regulatory submissions in all participating countries as Regulatory Lead.
• Regulatory submission of Clinical Trial in the region
• ​​​Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
• You may lead or be involved in local, regional, and/or global projects
• Guide and mentor junior team members

Skills and Experience required for the role:

• University degree in a science discipline
• Background in clinical trial management
• 3-5 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
• Experience with clinical trial submissions in other Southern African Countries
• IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
• Customer-oriented and autonomous
• Fluency in English is a must along with the local language.