Senior Regulatory Writer

Proclinical is currently seeking a Senior Regulatory Writer for a global specialty pharmaceutical company. Successful candidate will connect and support project teams across multiple compound and/or projects to ensure the development of high-quality, message-focused, submission-ready, regulatory documents.

Job Responsibilities

• Plan, write, edit, and review regulatory documents.
• Collaborate with document authoring teams to establish document key messages, timelines, and priorities.
• Conducts document kick-off meetings, participate in timeline planning, and facilitate cross-functional document development as ad hoc member of Global Regulatory Project Teams.
• Manage review and approval workflows in the electronic document management system.
• Develop processes and SOPs for Regulatory Writing.
• Provide input into resource forecasting for projects; establish vendor requirements for Regulatory Writing needs; and oversee vendors providing regulatory writing services when applicable.
• Provide guidance to project team members unfamiliar with or inexperienced in regulatory document requirements.

Skills and Requirements

• BS with regulatory or medical writing experience in the pharmaceutical/ biotechnology/medical device industry.
• 7+ years of drug/biologics development experience with 5+ years' experience in the development of regulatory documents for Health Authority submission.
• Experience in assembling scientifically complex data or information to support Key Messages; able to convert data and information that meets clinical regulatory requirements.
• Knowledge of EDMS systems, regulatory publishing, and preparation of regulatory submissions.
• Demonstrated expertise with Microsoft Office programs and document templates.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4385 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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