Jobs Available at PAREXEL

You will support Statistical Programming group in analyzing and reporting clinical trials. Your tasks include:

• Producing datasets (for statistical analysis and regulatory submission purposes), statistical outputs such as statistical tables and graphs as well as data listings, utilizing SAS® Software.
• Learn about the pharmaceutical industry, what is involved in conducting a clinical trial and getting a new drug to market, as well as good clinical practices.
• On your Parexel journey, we support you with leading-edge technology, the highest caliber team members, and managers who know your strengths. If you’re looking for flexibility and work-life balance, we’re here to listen and help you move forward with your individual career path. As a large multinational company, you may also work closely with colleagues in other locations such as Asia or North America. This is a great opportunity to develop skills and experience to help you during the final year of your degree course.

Qualifications:

• BSc/MSc student studying a degree in statistics, mathematics, computer sciences, computer and management studies.
• Knowledge of a statistic methods application such as SAS®, R, MATLAB, SPSS
• Ability to prioritize work and meet deadlines.
• Ability to work and communicate in a global project team environment.
• Self-motivated with a desire to develop and learn new skills.
• Be part of our empowered Parexel Statistical Programming team and contribute to our patients first approach

Required Skills:

• Excellent analytical skills
• Knowledge of SAS
• Knowledge and understanding of the programming and reporting process.
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Ability to learn new systems and function in an evolving technical environment.
• Attention to detail.
• Ability to successfully work as part of a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.

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Key Deliverables in the role:

• Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead.
• Regulatory submission of Clinical Trial in South Africa
• ​​​Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
• You may be involved in local, regional, and/or global projects

Skills and Experience required for the role:

• University degree in a science discipline
• Background in clinical trial management
• 1-2 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
• Experience with clinical trial submissions in other Southern African Countries - preferred
• Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
• IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
• Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.
• Customer-oriented and autonomous
• Fluency in English is a must along with the local language.

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Key Accountabilities:

Author Clinical Documents

• Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.
• Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.

Quality Control

• Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.

Project Management

• Operate as the project lead writer/submission coordinator and primary client Management contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project.
• Develop, coordinate, and oversee work plans for individual and multiple document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives.
• Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. 

Client Liaison/Service

• Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.
• Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon.

Training/Compliance

• Keep abreast of new advances in medical writing and regulatory issues.
• Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management.
• Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate.

General 

•  Attend departmental and company meetings as necessary.
• Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform
• Analyze efficiency of work and discuss improvement ideas with Medical Writing Services management and colleagues.

Education:

• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent

Skills:

• Excellent interpersonal, negotiation, verbal, and written communication skills.
• A flexible attitude with respect to work assignments and new learning.
• Motivation to work consistently in a fast-paced, rapidly changing environment.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
• Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
• Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.
• Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
• Understands and satisfies client needs.
• Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.

Knowledge and Experience:

• Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
• Extensive clinical/scientific writing skills acting as either a Senior Medical Writer or Principal Medical Writer
• Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
• Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
• Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.