Principal Regulatory Operations Publisher

🔥 14 hours ago

🌐 United States, Canada, +1 more countries – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote 🇮🇳 India – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $100k - $120k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Veristat

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 Private equity on 2021-05

Consulting • Healthcare • Pharmaceuticals

Veristat is a clinical development services company that provides end-to-end, regulatory-focused support for biopharmaceutical and medical device sponsors. The firm offers full-service clinical trial planning and conduct, regulatory affairs and submission support (including NDA/MAA and interactions with agencies like PMDA), statistical and biometrics services, medical writing, pharmacovigilance, and project management for complex therapeutic areas such as oncology, rare diseases, neurology, biologics, and cell & gene therapies. Veristat operates as a B2B partner to biotech and pharmaceutical organizations to reduce development risk and accelerate regulatory approval.

📋 Description

• Independently lead publishing projects to successful completion • Internally support Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams • Lead the finalization and publishing of regulatory documents for electronic submission • Represent the Regulatory Operations group in critical business activities • Mentor junior team members • Act as a point of escalation for technical questions and troubleshooting

🎯 Requirements

• Bachelor’s Degree, preferably in a scientific discipline, with at least 8 years of relevant experience in regulatory publishing in a contract research organization (CRO), pharmaceutical, biotechnology, or other clinical setting required • Proficiency in Adobe Acrobat, ISIToolbox, publishing software (e.g., eCTDmanager, DocuBridge, eCTDXpress, etc.) and advanced formatting using Microsoft Word styles and templates, including EndNote software required • Demonstrated ability to effectively lead a project team required • Demonstrated ability to independently manage major dossier submissions or amendments of varying complexity and scope required • Experience with global submissions (including FDA and EMA) and post-marketing submissions strongly preferred • Excellent writing skills (eg, English usage), a keen attention to detail, and strong verbal and interpersonal communication skills required; ability to serve as a consultative partner therein • Proficiency with medical and statistical terminology required • Ability to communicate and collaborate effectively in project teams required

🏖️ Benefits

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans • Applicable bonus

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume