Director, Regulatory Writing

Job not on LinkedIn

🔥 18 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $220k - $249.7k / year

⏰ Full Time

🔴 Lead

✏️ Content Writer

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This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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TScan Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

TScan Therapeutics is a clinical-stage biopharmaceutical company dedicated to changing lives by discovering new cancer targets and developing safe and effective T cell therapies for patients. Their innovative approach involves leveraging insights from patients who have successfully fought cancer to inform the development of new treatments. TScan is focused on unleashing the untapped potential of the human immune system to create impactful T cell therapies for various malignancies.

📋 Description

• Lead planning and management of regulatory submission components from preclinical through registration phases • Author or coordinate clinical protocols and amendments, Investigator's Brochures, Development Safety Update Reports, clinical study reports, health authority meeting requests and briefing documents, and IND, CTA, CTR, and NDA summary documents • Manage external resources and coordinate communication with internal contributors and stakeholders • Serve as lead author and/or document expert for critical deliverables • Represent Regulatory Writing on cross-functional teams with subject matter experts, Regulatory Affairs, and Program Management • Develop, maintain, and improve SOPs, authoring guides, and project management tools • Support submission-related activities with Regulatory Affairs • Build relationships with Regulatory colleagues, cross-functional project teams, and external stakeholders to achieve timelines and portfolio deliverables

🎯 Requirements

• BS or MS with at least 7 years of increasing responsibility as a regulatory / medical writer • Education in a scientific field is a plus • Demonstrated track record in medical writing within the pharmaceutical, biotech, or CRO industry, particularly creating and updating clinical development documentation • Experience managing external resources is a plus • Expertise with Microsoft Word and eCTD-compliant formatting requirements • Proficiency organizing and interpreting complex scientific and clinical data • Strong understanding of ICH, GCP, and FDA regulatory standards governing regulatory documentation • Experience with rare diseases, pediatrics, genetic medicines, or expedited development pathways is strongly preferred • Experience in Duchenne muscular dystrophy or neuromuscular therapeutic areas is a plus • Excellent project management skills and ability to work on multiple projects with tight timelines • Strong work ethic, excellent communication skills, collaborative approach, proactive work style, results-oriented mindset, integrity, desire to learn and grow, and commitment to excellence

🏖️ Benefits

• Comprehensive health, dental and vision coverage • Life and disability insurance • 401(k) match • Paid, gender-inclusive parental leave • Holistic support for health and well-being • Education reimbursement • Discretionary time off • Commuting benefits aligned to the working model

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