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.

Requirements

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.