argenx
Director of Medical Writing
United States - Remote · Director
Sponsorship not specified$212k-$292kDetected 27 days ago
Computer VisionResearchLeadershipCommunicationTime ManagementMicrosoft Office
About the role
- This individual will contribute to the development and execution of the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives.
- This range reflects our good faith estimate at the time of posting.
- This means actual pay may differ from the posted range when justified by these factors.
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
- Collaborates with project teams to ensure project deadlines are met by providing content development support, research, and editing functions for each program
- o Author (20%) content and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx MW standards, company SOPs, style guide, lexicon, templates, and libraries
- o Author (80%) content and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx MW standards, company SOPs, style guide, lexicon, templates, and libraries
- Looks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to achieving objectives
Nice to have
- Bachelor's degree in a scientific or clinical discipline or related field required
Skills
- Bachelor's degree in a scientific or clinical discipline or related field required; Ph.D. preferred
- Native/bilingual or fluent American English proficiency
- Can provide solutions in creative, effective, and constructive ways
- eCTD Module 5 and Module 2 writing experience for global MAAs
- Understands the interrelationships of various disciplines within the organization and can effectively navigate
- Solution-focused and experience leading teams
- Has managed direct reports (overseeing contract medical writers may be considered)
- Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion
- 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
Compensation
- The annual base salary hiring range for this position is $212,000.00 - $291,500.00 USD.
Benefits
- Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity.
- It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.
- Responsible for inspection-readiness of medical writing activities
- Mentors less experienced medical writers and develops and implements training to support medical writers and cross-functional teams
- Responsible for medical writers assigned to support the medical writing activities for a particular project
- o Manage (80%) medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
- o Manage (20%) medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
- Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
Equal opportunity
- If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com.
- Only inquiries related to an accommodation request will receive a response.
Visa & Work Authorization
- Minimum of 7 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.