Job Description

Join to apply for the Senior Medical Writer role at TalentAlly 2 days ago Be among the first 25 applicants Join to apply for the Senior Medical Writer role at TalentAlly 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 privacy@argenx.com . 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. 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 Referrals increase your chances of interviewing at TalentAlly by 2x Get notified about new Senior Medical Writer jobs in Chicago, IL . 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