Job Description

Employer Industry: Biopharmaceuticals Why consider this job opportunity Opportunity for career advancement and growth within the organization Competitive salary and benefits package Supportive and collaborative work environment Engage in impactful work that contributes to the treatment of autoimmune diseases Strong emphasis on innovation and scientific excellence Remote work flexibility with a preference for candidates located on the East Coast What to Expect (Job Responsibilities) Serve as the primary point of contact for CRO medical writing teams, ensuring alignment with company standards and timelines Provide document-level guidance, review, and final approval oversight for CRO-authorized deliverables Develop and maintain medical writing governance frameworks, including SOPs and quality control processes Support internal writers and reviewers in collaborating effectively with CRO partners Ensure quality review and continuous improvement initiatives within the medical writing outsource model What is Required (Qualifications) PhD or advanced degree in a scientific or clinical discipline or related field required Minimum of 5 years of sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience required Strong organizational, communication, and influencing skills Fluent American English proficiency with excellent written and verbal communication skills Solid understanding of ICH, GCP, and global regulatory submission requirements (FDA, EMA, PMDA, etc) How to Stand Out (Preferred Qualifications) Proficiency in document management and collaborative authoring platforms (Veeva Vault, Please Review preferred) Ability to work autonomously and collaboratively in a team Excellent attention to detail and ability to prioritize and multitask successfully in a fast-paced environment Basic understanding of scientific methodology as applied to drug development Strong preference for individuals located on the East Coast #Biopharmaceuticals #MedicalWriting #CareerOpportunity #Innovation #RemoteWork We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer. #J-18808-Ljbffr argenx

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