This is a fully remote position, open to applicants in United States, +3 more locations.

📋 Description

• Take charge of publishing projects and guide them to successful outcomes.

• Provide internal support to teams in Medical Writing, Biostatistics, Programming, and Regulatory Affairs.

• Oversee the completion and publication of regulatory documents for electronic submission.

• Represent the Regulatory Operations team in key business activities.

• Mentor and support junior team members.

• Serve as a point of escalation for technical inquiries and problem-solving.

⛳️ Requirements

• A Bachelor’s Degree, preferably in a scientific field, along with a minimum of 8 years of relevant experience in regulatory publishing within a contract research organization (CRO), pharmaceutical, biotechnology, or similar clinical environment is 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 is essential.

• Proven ability to effectively lead a project team is required.

• Demonstrated capacity to independently manage major dossier submissions or amendments with varying complexity and scope is necessary.

• Experience with global submissions (including FDA and EMA) and post-marketing submissions is strongly preferred.

• Excellent writing abilities (e.g., command of English), meticulous attention to detail, and strong verbal and interpersonal communication skills are essential; the ability to act as a consultative partner is required.

• Proficiency in medical and statistical terminology is necessary.

• Ability to communicate and collaborate effectively within project teams is required.