-
Communication and Social Media Officer at
4 days ago
City Health Hospital Nairobi, Kenya Full timeCity Health Hospital is a leading medical facility established by distinguished medical professionals who share a common concern for public health and human dignity. · Salary Range : KSh 30,000 - KSh 50,000/month · Key Responsibilities: · Develop creative concepts, layouts and ar ...
-
Information Communication Technology Officer
5 days ago
Kenya Medical Training College (KMTC) Nairobi, Kenya Full timeWhen you choose to launch your medical career at KMTC, you join more than 26,000 students at the College who aspire to improve the health of communities they live in.When you join one of the 50-plus specialized courses offered at KMTC, you will be a part of the biggest human reso ...
-
Assistant Principal Clinical Scientist at
1 week ago
Kenya Medical Research Institute - KEMRI Nairobi, Kenya Full timeKenya Medical Research Institute (KEMRI) is a State Corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013. The 1979 Act established KEMRI as a National body responsible for c ...
-
Medical Officers
3 days ago
Zuri Health Nairobi, Kenya Full timeFounded in February 2020, our journey started with a vision. A vision for quality, affordable and on-demand healthcare for all with a simple swipe. We are creating an all-inclusive service that caters for all individuals with a mobile device, regardless of their location, health ...
-
Medical Specialist II
1 week ago
Kenyatta National Hospital Nairobi, Kenya Full timeKNH has turned 115 years and it had its Centenary Celebration in 2001. The Hospital was built to fulfill the role of being a National Referral and Teaching Hospital, as well as to provide medical research environment · Job Purpose · The Medical Specialists (Paediatric Surgery) ar ...
-
Systems Maintenance Engineers at
4 days ago
Med-Lab Diagnostics Center Nairobi, Kenya Full timeOur story began in 2010 as a small medical reference laboratory with less than 10 employees. We soon discovered that the needs of our practitioners and our clients required us to implement mobile phlebotomy. · Responsibilities · Design maintenance strategies, procedures and metho ...
-
Security Support Assistant
3 days ago
U.S. Embassy to Kenya Nairobi, Kenya Full timeThe U.S. Embassy to Kenya opened in 1964. Through sixteen Ambassadors since then, the Embassy has enriched the ties between the American and Kenyan people and served the needs of Americans in and around this East African hub. · Duties · The incumbent provides security support to ...
-
Agency Manager – Machakos, Mombasa at
2 hours ago
The Kenyan Alliance Insurance Nairobi, Kenya Full timeThe Kenyan Alliance Insurance is a leading Insurance and Financial Services Company offering a wide range of financial products and services in insurance. The product range includes life and general insurance, pensions, investment planning, wealth management, retirement planning ...
-
Clinical Officer at Bethesda Healthcare Services
2 hours ago
jobwebkenya Nairobi, Kenya Full timeBethesda Health Care Services Company Limited is situated in Nandi County, Nandi Hills town along the Hospital road next to Olympic Service Station. · Summary · The incumbent will be responsible for providing efficient, effective, quality clinical services to patients following e ...
-
Project Coordinator at
1 day ago
Flexi-Personnel Nairobi, Kenya Full timeFlexi Personnel Ltd is a HR Company that was founded in 2008. It is currently the fastest growing HR firm in Kenya offering a wide range of services including Headhunting and Executive selection, Outsourced Labor management, HR Outsourcing, Outsourced Payroll Management, HR consu ...
-
Registered Nurse
1 week ago
U.S. Embassy to Kenya Nairobi, Kenya Full timeThe U.S. Embassy to Kenya opened in 1964. Through sixteen Ambassadors since then, the Embassy has enriched the ties between the American and Kenyan people and served the needs of Americans in and around this East African hub · Duties · The incumbent serves as the post's nurse wit ...
-
Medical Specialist II
1 week ago
Kenyatta National Hospital Nairobi, Kenya Full timeKNH has turned 115 years and it had its Centenary Celebration in 2001. The Hospital was built to fulfill the role of being a National Referral and Teaching Hospital, as well as to provide medical research environment · Job purpose · The Medical Specialists (Radiology) are respons ...
-
Kenya Medical Training College (KMTC) Nairobi, Kenya Full timeWhen you choose to launch your medical career at KMTC, you join more than 26,000 students at the College who aspire to improve the health of communities they live in.When you join one of the 50-plus specialized courses offered at KMTC, you will be a part of the biggest human reso ...
-
Medical Officer
1 week ago
Kenyatta University Teaching, Referral & Research Hospital Nairobi, Kenya Full timeKenyatta University Teaching, Referral & Research Hospital (KUTRRH) is a leading National Referral Hospital with a 650 bed capacity and equipped with state-of-art medical amenities. The hospital is well equiped to offer Oncology, Trauma & Orthopedics, Renal among other services. ...
-
Clinical Research Scientist at
1 week ago
Kenya Medical Research Institute - KEMRI Nairobi, Kenya Full timeKenya Medical Research Institute (KEMRI) is a State Corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013. The 1979 Act established KEMRI as a National body responsible for c ...
-
Clinical Officer
2 days ago
Central Bank of Kenya Nairobi, Kenya Full timeThe Central Bank of Kenya is a public institution established under Article 231 of the Constitution of Kenya, 2010. The Bank is responsible for formulating monetary policy to achieve and maintain price stability and issuing currency · Job Purpose · As a healthcare professional, t ...
-
Assistant Professor, Epidemiology
1 day ago
Aga Khan University Nairobi, Kenya Full timeABOUT THE COMPANY · Aga Khan University's vision is to serve the developing world and Muslim societies in innovative and enduring ways. It is committed to the development of human capacities through the discovery and dissemination of knowledge, and application through service. · ...
-
Medical Officer at
3 days ago
Halisi Family Hospital Nairobi, Kenya Full timeHalisi Family Hospital is a multi-specialty 25-bed inpatient and outpatient hospital in Kitengela, Kajiado county. · Role Summary · Ensure high quality health and wellness services are given to all patients through provision of evidence-based clinical care and through continuous ...
-
Registered Nurse
1 week ago
U.S. Embassy to Kenya Nairobi, Kenya Full timeThe U.S. Embassy to Kenya opened in 1964. Through sixteen Ambassadors since then, the Embassy has enriched the ties between the American and Kenyan people and served the needs of Americans in and around this East African hub. · Duties · The incumbent serves as the post's nurse wi ...
-
Payroll, Compensations
2 days ago
M.P. Shah Hospital Nairobi, Kenya Full timeM.P. Shah Hospital is a modern 210-bed facility which is home to highly skilled and experienced specialists and professional medical staff. · Duties & Responsibilities: · Prepare and process the staff monthly payroll in an accurate and timely manner; · Ensure timely submission o ...
Associate Director, Medical Writing at - Nairobi, Kenya - International AIDS Vaccine Initiative (IAVI)
Description
The International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.
Position Summary:
Are you an experienced Medical Writer who is eager to help translate science into global health solutions?
Summary
IAVI is seeking an experienced Medical Writer to lead medical writing within the 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 Associate Director 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 experience in clinical research and are eager to join a mission-driven organization, learn more and apply belowKey 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.Review, revise, and improve current templates, SOPs, and process documents for medical writing operations, as well as developing new templates and SOPs where appropriate.
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.Requirements
Education and Work Experience:
Master's degree or PhD in life sciences, clinical sciences, or related field is required.
Minimum of 8 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.