Senior Manager, Global Regulatory Writing

What you will do

In this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards

• Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4)
• Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety documents, across therapeutic areas and for biosimilars (mandate)
• Write other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)
• Manage study timelines for regulatory documents and regulatory submission strategy
• Act as a functional area representative and lead on product teams
• Manage, train and mentor medical writers
• Manage the work of GRW staff
• Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
• Ensure quality of regulatory submission documents at all stages of development
• Provide expertise and guidance on document design and principles of good medical writing to the department and product teams
• Participate in departmental meetings, as well as departmental and cross-departmental initiatives, as appropriate

Basic Qualifications:

• Masters degree and 13-17 years of Writing Regulatory or scientific submission/documents experience

Preferred Qualifications:

• Experience in writing clinical and regulatory documents
• Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
• Ability to analyze medical data and interpret its significance
• Advanced knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
• Advanced written/oral communication skills and attention to detail
• Understanding and application of principles, concepts, theories and standards of scientific/technical field
• Strong time and project management skills, negotiating skills, and perseverance with a drive for results
• Knowledge of management skills and supervising the work of others
• Strong leadership in a team environment
• Strong negotiator
• Experience in mentoring, training, and directing others