Medical Writer or Senior Medical Writer

Job Description

About the job

Position Description

Job Title: Medical Writer or Senior Medical Writer

Location: Nairobi, Kenya, Cape Town, South Africa or Remote in South Africa

Reports to: Senior Medical Director, Clinical Development

Position Summary

Are you an experienced Medical Writer who is eager to help translate science into global health solutions?

IAVI is seeking an experienced Medical Writer to join our Clinical Development department and lead a number of writing initiatives including (but not limited to) drafting protocols, clinical study reports, Investigator Brochure’s, Investigational New Drug Applications, and other regulatory and scientific documents. The Medical Writer will lead all clinical writing activities outlined in the Project Clinical Development plans, as well as review documents, and provide guidance in preparation of regulatory and publication documents.

If you have medical writing in clinical research and are eager to join a mission-driven organization, learn more and apply below!

Key Responsibilities

• Research, draft, and edit protocols, clinical study reports, and summarize data from clinical studies for publication and presentation as well as for submission to the FDA and other regulatory agencies.
• Research, draft, and edit clinical evaluation plans, clinical evaluation reports, clinical summary and overview documents in CTD/eCTD format for regulatory submissions, including IMPDs, INDs, MAAs, NDAs, variations and supplemental NDAs.
• Provide medical writing deliverables covering all phases of clinical research, and in various therapeutic areas, by working with relevant Department Heads and staff in Clinical Development, Clinical Operations, Data Management, Biostatistics, Quality, and Regulatory Affairs.
• Serve as representative and SME for all medical writing related tasks for the cross-functional clinical team.
• Adhere to established regulatory standards, Company Standard Operating Procedures (SOPs), and company-approved templates, and ensure written documents are in compliance with all regulations (ICH, GLPs, and GCPs).
• Develop, plan, and track cross-functional delivery of clinical documents and medical writing deliverables and sub-deliverables.
• Serve as a departmental resource for training, mentoring, and the development of process improvements for medical writing.
• Collaborate with the Senior Specialist, Information for on-line clinical literature searches.
• Support the development, improvement, and maintenance of the Departmental Guidelines Management System, writing style guides and formats, and departmental templates.
• Review statistical analysis plans and table/figure/listing specifications for appropriate content and consistency.
• Maintain knowledge, and updates team, of current industry practices and latest professional, technological, and regulatory developments in medical writing and therapeutic areas.
• Occasionally research, draft, edit, and coordinate the review of non-clinical medical and scientific reports and documents.
  
  

Education And Work Experience

• Master’s degree or PhD in life sciences, clinical sciences, or related field is required.
• Minimum of 3 years’ experience with regulatory writing and authoring clinical protocols and clinical study reports is required; Minimum of 5 years experience required for Senior Medical Writer.
• Medical writing experience in a pharmaceutical, biotech, or CRO is required.
  
  

Qualifications And Skills

• Familiarity and experience with principles of clinical research, and the ability to interpret and present clinical data and other complex information is required.
• Understanding of FDA and ICH regulations and guidelines is required.
• Detailed oriented with excellent grammatical, editorial, and proofreading skills is required.
• Flexibility to switch between changing priorities and deadlines to meet organizational needs is required.
• Ability to work well independently as well as with internal and external teams while exercising discretion is required.
• Takes the initiative to resolve problems is required.
• Highly proficient with MS Word, Excel, PowerPoint, and EndNote is required.
• Experience in Infectious Diseases, including HIV and TB, and emerging infectious diseases as well as vaccine and antibody trials is highly desirable.
• Experience with EDMS (e.g., Documentum, Core Dossier) is highly desirable.
  
  

Organizational Overview

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

Iavi Core Values

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference
  
  

Disclaimer: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.

IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)