Senior Manager, Medical Writing

at  IAVI

POSITION DESCRIPTION

Job Title: Senior Manager, Medical Writing
Location: Cape Town, South Africa; South Africa - Remote, Nairobi, Kenya
Reports to: Senior Director, Clinical Operations
Are you an experienced Medical Writer who is eager to help translate science into global health solutions?
IAVI is seeking an experienced Senior Manager, Medical Writing to join our Clinical Development department and lead writing initiatives together with project development teams, including (but not limited to) drafting protocols, clinical study reports, Investigator Brochure’s, Investigational New Drug Applications (INDs), and other regulatory and scientific documents. The Senior Manager will lead clinical writing activities outlined in Project Clinical Development plans in accordance with Standard Operating Procedures (SOPs), industry standards and updated Regulatory guidelines, and will assist in the research and writing of publications according to journal requirements.
If you have Medical Writing experience in Regulatory Writing within the clinical research industry and are eager to join a non-for-profit mission-driven organization within the Infectious Disease industry, learn more and apply below!

EDUCATION AND WORK EXPERIENCE:

• Advanced degree in life sciences, clinical sciences, or related field is required; PhD or MD degree preferred.
• Minimum of 5 years’ experience as a Medical Writer in Regulatory Writing including clinical study protocols and clinical study reports is required.
• Medical writing experience within 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 ICH, FDA, and EU regulations and guidelines is required, and other relevant African regulations is highly desirable.
• Detailed oriented with excellent grammatical, editorial, and proofreading skills.
• Flexibility to switch between changing priorities and deadlines to meet organizational needs.
• Ability to work well independently as well as with internal and external teams while exercising discretion.
• Takes the initiative to resolve problems.
• Highly proficient with MS Word, Excel, PowerPoint, and EndNote is required.
• Proficiency in Electronic Trial Master File platforms and SharePoint is highly desirable.
• Experience in Infectious Diseases, including HIV and TB, and emerging infectious diseases as well as vaccine and antibody studies is highly desirable.

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.

• Research, draft, implement comments, 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.
• Assist in research and write publications according to journal requirements.
• Provide medical writing deliverables covering all phases of clinical research, and in various therapeutic areas, 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 SOPs, and company-approved templates, ensuring written documents are compliant with all regulations (ICH GCP, FDA, and EU [others if needed]).
• Develop, plan, and track cross-functional delivery of clinical documents and Medical Writing deliverables and sub-deliverables.
• Collaborate with the Senior Specialist, information for online clinical literature searches.
• Support the development, improvement, and maintenance of the Departmental Guidelines Management System.
• Review statistical analysis plans and table, figures, and listings specifications for appropriate content and consistency.
• Support the review, revision, and improvement of current templates, SOPs, and process documents for Medical Writing operations, as well as assisting with the development of new templates and SOPs, where appropriate.
• Maintain knowledge 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 nonclinical medical and scientific reports and documents.
• Support in the development of any other documents as needed.