Senior Medical Writer

TalentAlly; Chicago (IL); On-site; USD 56,000 - 83,000; Full time

Job summary

TalentAlly seeks a Senior Medical Writer to support the creation of regulatory documents for a leading biotech firm. This role is crucial for ensuring compliance and clarity in complex medical writing tasks. The ideal candidate will have significant experience in clinical writing and a strong educational background in scientific disciplines.

Qualifications

• 3 years of clinical/regulatory medical writing experience required.
• Familiarity with pharmacovigilance guidelines.
• Basic understanding of drug development.

Responsibilities

• Develop content for regulatory submissions.
• Responsible for inspection-readiness of medical writing activities.
• Project manage SME contributions.

Skills

American English proficiency

Solution-focused

Excellent written and verbal communication skills

Excellent time management skills

Ability to work autonomously

Education

Bachelor's degree in a scientific or clinical discipline

Ph.D. preferred

Tools

Veeva Vault

MS Office

Job description

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Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class 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 science-based start-up 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.

For the expansion of our team, argenx is looking for a Senior Medical Writer who will provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions.

This individual will execute the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives.

Key Accountabilities/Responsibilities

• Author and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx Medical Writing standards, including style guide, lexicon, templates, and libraries
• Authors content for phase 1-4 protocols, master ICFs, IBs, and CSRs
• Responsible for inspection-readiness of medical writing activities
• Supports the lead writer and project teams to ensure project deadlines are met
• Executes corporate objectives, goals, measures, and strategies
• Capable of working on multiple deliverables simultaneously
  
  

Desired Skills And Experience

• Bachelor's degree in a scientific or clinical discipline or related field is required; Ph.D. preferred
• Minimum of 3 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
• Native/bilingual or fluent American English proficiency
• Solution-focused
• Experience with Veeva Vault and Please Review
• Experience with implementing lean writing techniques
• 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
• Familiarity with pharmacovigilance guidelines and developing aggregate reports
• Ability to work precisely according to procedures and regulations
• Ability to prioritize and multi-task successfully in a fast-paced environment
• Ability to work autonomously, as well as in a team
• Excellent written and verbal communication skills
• Excellent time management skills and a proven ability to work on multiple projects at any given time
• Must be proficient in MS Office
  
  

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.

Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates ("argenx") will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at [e-mail].

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at [e-mail]. Only inquiries related to an accommodation request will receive a response.

PDN-9f2c54c7-30a8-43b7-8c59-bab6233cbfca

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider

• Industries

  Technology, Information and Media

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