argenx
Associate Director, Medical Writing
Canada - Remote · Director
Sponsorship not specified$143k-$193kDetected 4 days ago
Computer VisionPharmacovigilanceCommunicationTime ManagementMicrosoft Office
About the role
- This individual will contribute to and execute the overall strategy for all medical writing processes to according argenx medical writing standards standards and corporate objectives.
- At argenx, all applicants are welcomed in an inclusive environment.
Responsibilities
- Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience
- Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs
- Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
- Ability to proofread documents for compliance with internal and external guidance documents
Requirements
- If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com.
Nice to have
- Bachelor's degree in a scientific or clinical discipline or related field required
- Familiarity with Veeva Vault and Please Review preferred
Skills
- Bachelor's degree in a scientific or clinical discipline or related field required; PhD preferred
- Native/bilingual or fluent American English proficiency
- Solution-focused
- eCTD Module 5 and Module 2 writing experience for global MAAs
- Ability to approach issues from various perspectives and accurately summarize data to provide conclusions
- Ability to work precisely according to procedures and regulations
- Excellent written and verbal communication skills
- Ability to prioritize and multi-task successfully in a fast-paced environment
- Ability to work autonomously, as well as collaboratively in a team
- Excellent time management skills and a proven ability to work on multiple projects at any given time
- This job posting is for an existing vacancy in the organization.
- Must be proficient in MS Office
Compensation
- The salary range for this role will be between $142,500.00 - $192,500.00 CAD.
Benefits
- Responsible for inspection-readiness of medical writing activities
- Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
- Collaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are met
- Responsible for medical writers assigned to support the medical writing activities for a particular project
- Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
- Knowledgeable in the regulatory guidances developed for documents authored by medical writing
Visa & Work Authorization
- Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
This listing is sourced directly from argenx's careers page and normalized into a canonical job model.