Director of Medical Writing
Director of Medical Writing
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Job Description
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multidimensional expansion to reach more patients through a rich pipeline of differentiated assets led by VYVGART our firstinclass neonatal Fc receptor blocker approved for the treatment of gMG and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company one that maintains its roots as a sciencebased startup and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company our partnerships our science and our people because when we do we deliver more for patients.
argenx is a clinicalstage biopharmaceutical company creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinicalstage portfolio of novel product candidates tailored from discovery through development to address patient needs.
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 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 (inhouse 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 wellorganized consistent accurate and compliant with argenx MW standards company SOPs style guide lexicon templates and libraries
OR
Writing focus
o Manage 20 medical writers (inhouse 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 wellorganized consistent accurate and compliant with argenx MW standards company SOPs style guide lexicon templates and libraries
AND
Primary author of phase 14 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 wellorganized consistent accurate and appropriate for a regulatory audience
Responsible for inspectionreadiness 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 inspectionreadiness of medical writing activities
Mentors less experienced medical writers and develops and implements training to support medical writers and crossfunctional 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 indepth 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:
Bachelors degree in a scientific or clinical discipline or related field required; Ph.D. preferred
Minimum of 7 years of related sponsorlevel 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
Solutionfocused 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 multitask successfully in a fastpaced 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
#LIRemote
At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
If you require reasonable accommodation in completing your application interviewing or otherwise participating in the candidate selection process please contact us at . Only inquiries related to an accommodation request will receive a response.
Required Experience:
Director
Employment Type
Full-Time
