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!
- 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 5 years’ experience with regulatory writing and authoring clinical protocols and clinical study reports is required.
- 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.
Director OR Senior Director, Regulatory Affairs
Are you an experienced Regulatory Affairs leader who’s eager to help bring vaccines and other cutting edge health solutions to market? Join IAVI and help us translate science into global health solutions!
IAVI is seeking an experienced a Director or Senior Director of Regulatory Affairs to serve as a regional lead for clinical trials throughout Africa. The leader will support regulatory activities to help advance products to licensure. This leader will develop and implement regulatory strategies and manage submission processes for a portfolio of products of vaccines and biologics in development to treat HIV/AIDs, TB, and other emerging infectious diseases impacting lower- & middle-income countries. The Sr. Director will also help improve and expand the capacity and infrastructure of IAVI regulatory affairs.
The Director (Or Senior) of Regulatory Affairs serves as a regional lead for IAVI sponsored clinical trials being conducted in Africa and supports regulatory activities to advance products to licensure. These trials could include different biological products being developed for the prevention and treatment of HIV/AIDS, emerging infectious diseases, TB, and other targets that are the focus of IAVI efforts. The Director develops and implements regulatory strategies and manages the submission processes for a portfolio of products. The Director also supports ongoing activities to improve and expand the capacity and infrastructure of the Regulatory Affairs department.
- In collaboration with the global team, the incumbent will work to identify, develop, and utilize plans needed to support both early and later phase clinical trials of HIV vaccines and other experimental vaccines and/or biologics across various disease areas.
- Engagement with regulatory agencies to gain acceptance and concurrence for trials to be conducted in Africa.
- Serve as the primary point of contact with regulatory agencies for assigned projects in scheduling and leading meetings, maintaining communication, and responding to queries for active submissions.
- Work within the project team structure to support multi-national clinical trials ensuring a harmonized approach that is aligned with the overall product development strategy.
- Manage critical issues and identify required activities to ensure that regulatory submissions are accurate and appropriate and completed with the project timeline.
- Provide leadership and management of junior regulatory team members and consultants.
- Provide training and guidance to other department members in areas of expertise.
- Perform other tasks as assigned by the Executive Director.
Education and Work Experience:
- MS or PhD in life sciences or related field is required.
- Minimum of 10 years’ experience (for Director) or minimum of 12 years’ experience for Senior Director, in regulatory affairs with related vaccine or biologics, including experience with regulatory authorities in sub-Saharan Africa.
- Experience in working with regulatory consultants and contract research organizations is required.
- Experience in working with regulatory agencies in West Africa is desirable.
Qualifications and Skills:
- Excellent organizational skills are required.
- Excellent verbal and written communication skills are required and a good working knowledge of Microsoft Office applications.
- Knowledge and experience in the preparation of regulator dossiers for regulators in Africa.
- Knowledge of GMP, GLP, GCP and /or quality assurance and regulatory affairs associated with biological products is highly desirable.
Method of Application
Use the link(s) below to apply on company website.