Job Vacancies at PPD

PPD are looking for experienced Senior Clinical Research Associates who are interested to join our team working home based in South Africa but covering sites across the African continent. Our sustained year on year growth means that we are looking for exceptional clinical talent to join our team.
PPD is one of the world’s largest CRO's. As the trusted partner of some of the most innovative big pharma and biotech companies; our CRA's have the opportunity to work on challenging projects across a wide range of therapy areas. Our vision is to be the global leader in our industry; based on consistent quality and execution, exceptional customer-aligned service and constant innovation.

• You should thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, challenging projects. You will have excellent communication and interpersonal skills and are looking to work in a collegiate environment where you want to take true ownership for your work.
• In return we will offer you a positive and supportive working environment within one of the most engaged teams in the industry; who are truly recognised as the cornerstone of our success. We will provide you with meaningful and challenging work and the opportunity to acquire valuable personal and professional skills; through our best in class training and development.

Qualifications

• A minimum of 12 months on site monitoring experience
• University degree in a science related field or are a certified health professional
• In depth knowledge of ICH-GCP, South African and FDA requirements
• Experience of clinical trials in Africa
• Willingness and ability to travel across the African continent (high frequency travel)
• Excellent English skills
• Previous experience in the CRO industry would be advantageous

Preference will be given to employees from the designated groups in line with the provisions of the Employment Act No.55 or 1998 (and any amendments thereto), PPD’s recruitment policy and the Employment Equity Plan.

Organization

• Clinical Research Associates

Primary Location

• ZA-ZA-Johannesburg-Johannesburg ZA Woodlands Dr

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As part of our on-going growth, we are currently recruiting for a Senior Medical Writer to join our rapidly expanding team of over 90 regulatory writers based in Europe, North America and Asia Pacific.

• The Phase II-IV Medical Writing group, which is part of the Biostatistics Department, includes Writers who prepare documents in support of clinical trials and who assist Regulatory Affairs professionals with marketing applications, INDs, pediatric investigational plans, clinical trial applications, and other types of regulatory documents.
• Our writers possess strong leadership and project management skills, are creative problem solvers and decision makers, are engaging mentors and enthusiastic members of the department with an eagerness to continually improve our offerings and deliver a market leading service to our clients. In return, the medical writing department offers a highly competitive compensation package together with excellent opportunities for personal development and progression within the field. All within a friendly, fast paced and exciting environment.
• The Medical Writer collaborates with internal and sponsor team members to interpret, distill, and summarize complex data concepts. Other tasks include presentation of clinical messages in clinical study reports, summarization of preclinical and clinical studies for preparation of investigator's brochures, and referencing current research and regulatory guidelines for preparation of protocols. Their work documenting clinical study trials covers a wide range of therapeutic indications.

Qualifications Required

• Education to Bachelor’s/advanced degree level in a scientific discipline
• 3+ years of experience within regulatory medical writing
• Excellent grammatical, editorial and proofreading skills

The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. We offer a generous salary and benefits package as well as excellent learning and development opportunities. We understand that the best writers are not necessarily on our doorstep, so if you are looking for a home-based role we can offer this option to the right candidate, providing everything you need to fulfil your potential from your home office.

How to apply: Submit your CV in English.

PPD is equal opportunities employer.

Organization

• Medical Writing

Primary Location

• Europe, Middle East & Africa

Other Locations

• ES-Spain, GB-United Kingdom, ZA-South Africa

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Medical Writer - Early phases

• Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.
• May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.
• May assist in program management activities. Duties could include assisting with developing timelines, budgets, forecasts for assigned deliverables.
• Represents the department at project launch meetings, review meetings, and project team meetings.

Qualifications Required

• Education to Bachelor’s/advanced degree level in a scientific discipline
• 3+ years of experience within regulatory medical writing
• Excellent grammatical, editorial and proofreading skills
• CSR (clinical study report) early development study designs; Ib/2a patient-population experience
• Protocol development/early development study designs; Ib/2a patient-population experience
• ICH proficiency a must

Preferred Qualifications

• Industry guidance for Ph I/early development study designs
• Previous CRO experience

Skills And Knowledge Required

• Strong project management skills
• Strong decision-making, critical thinking and priortization skills
• Experience managing and delivering according to strict deadlines
• Ability to manage competing priorities

The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. We offer a generous salary and benefits package as well as excellent learning and development opportunities. We understand that the best writers are not necessarily on our doorstep, so if you are looking for a home-based role we can offer this option to the right candidate, providing everything you need to fulfil your potential from your home office.
How to apply: Submit your CV in English.

PPD is equal opportunities employer.
Organization

• Medical Writing

Primary Location

• Europe, Middle East & Africa

Other Locations

• GB-United Kingdom, ZA-South Africa