Senior Medical Writer

TalentAlly; New York (NY); On-site; USD 100,000 - 125,000; Full time

Job summary

A leading biotech company is seeking a Senior Medical Writer to contribute to regulatory submissions and ensure compliance with high standards. This role involves managing multiple deliverables in a fast-paced environment and requires significant expertise in medical writing and project management.

Qualifications

• Minimum of 3 years of related medical writing experience.
• Native/bilingual or fluent American English proficiency required.
• Experience with lean writing techniques.

Responsibilities

• Author and manage regulatory submissions in accordance with argenx standards.
• Support lead writer and project teams to ensure deadlines are met.
• Maintain inspection-readiness of medical writing activities.

Skills

Medical Writing

Project Management

Scientific Methodology

Excellent Communication

Time Management

Education

Bachelor's degree in a scientific or clinical discipline

Ph.D. (preferred)

Tools

MS Office

Veeva Vault

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

Get AI-powered advice on this job and more exclusive features.

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-9f2c54c7-4f94-4661-82b7-14e2fb434e82

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 New York, NY.

Medical Writer - Medical Communications - East Coast

New York City Metropolitan Area $60,000.00-$80,000.00 2 weeks ago

New York, NY $100,000.00-$125,000.00 1 week ago

New York, NY $220,000.00-$245,000.00 4 days ago

Medical Strategist/Writer (with ad agency and promo exp)

New York, NY $65,000.00-$96,000.00 1 week ago

New York, NY $160,000.00-$185,000.00 1 week ago

Newark, NJ $85,000.00-$95,000.00 3 weeks ago

New York City Metropolitan Area 1 week ago

Senior Medical Writer - Agency Experience REQUIRED

New York City Metropolitan Area $80,000.00-$110,000.00 4 weeks ago

New York City Metropolitan Area 3 weeks ago

Parsippany, NJ $157,590.00-$203,940.00 2 days ago

Associate Director, Medical Writing (Clinical Development)

Rahway, NJ $169,700.00-$267,200.00 4 days ago

Associate Director, Clinical Document Operations Lead

Parsippany, NJ $141,000.00-$194,000.00 2 weeks ago

New York, NY $244,000.00-$244,000.00 2 months ago

Associate Director (Hospitals) - Level III - Medical Clinic

Brooklyn, NY $92,143.00-$92,143.00 22 hours ago

Associate Medical Director, Medical Strategy & Scientific Affairs

New York City Metropolitan Area $110,000.00-$140,000.00 2 weeks ago

New York, NY $95,000.00-$120,000.00 3 days ago

Associate Medical Director - NYC Health + Hospitals/Gotham Health - Brooklyn

Associate Medical Director - NYC Health + Hospitals/Gotham Health, Morrisania

Bronx, NY $244,000.00-$244,000.00 2 months ago

Brooklyn, NY $170,000.00-$240,000.00 2 weeks ago

Medical Science Liaison I / New York/Philadelphia Region

New York, NY $134,000.00-$204,000.00 1 week ago

Medical Science Liaison I / New York/Philadelphia Region

New York, NY $156,000.00-$204,000.00 1 week ago

Associate Medical Director - NYC Health + Hospitals/Gotham Health - Queens Sites

Queens, NY $244,000.00-$244,000.00 2 months ago

Associate Director, External Manufacturing Operations - Medical Devices

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.