For the expansion of our team, argenx is looking for a Director of Medical Writing to manage medical writers and author content. This individual will also develop critical infrastructure for the maturation of the department.
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.
Roles and Responsibilities:Managing focus
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 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
OR
Writing focus
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
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
AND
- Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug development
- Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience
- Responsible for inspection-readiness of medical writing activities
- 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
- 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
- Contributes to the development of departmental strategy(ies)
- Participates in the development of corporate objectives, goals, measures, and strategies
- Ensures direct reports are executing corporate objectives, goals, measures, and strategies
- Directs activities of multifunctional projects and reconciles multiple stakeholder views
- Capable of working on multiple deliverables simultaneously
- Responsible for medical writers assigned to support the medical writing activities for a particular project
- Resolves complex issues in which situational or data analyses require in-depth evaluation of variable factors
- Determines methods and procedures for assignments
- May include roles that are key technical or subject matter experts providing professional or thought leadership
- Looks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to achieving objectives
Desired Skills and Experience:- Bachelor's degree in a scientific or clinical discipline or related field required; Ph.D. preferred
- Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
- 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)
- 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
- Knowledgeable in the regulatory guidances developed for documents authored by medical writing
- Ability to proofread documents for compliance with internal and external guidance documents
- 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
- Excellent time management skills and a proven ability to work on multiple projects at any given time
- Must be proficient in MS Office
#LI-Remote
For applicants in the United States: The annual base salary hiring range for this position is $212,000.00 - $291,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. 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.
