Regulatory Writing Manager

• Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents;
• Conduct the formal review and approval of authored documents, following applicable standard operating procedures;
• With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications;
• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
• May provide functional area input for Global Regulatory Plan and team goals
• May work with contract and freelance writers
• May participate in training and mentoring of junior medical writers
• May participate in departmental and cross-departmental initiatives, as appropriate.
• Generate document timelines, with team input
• Keep abreast of relevant professional information and technology

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of directly related experience OR
• Bachelors degree and 6 to 8 years of directly related experience OR
• Diploma and 10 to 12 years of directly related experience

Preferred Qualifications:

• Proficiency with word processing and other Microsoft Office Programs
• Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds;
• Ability to understand and follow complex standard operating procedures (SOPs), guidance documents, and work instructions;
• Understanding and application of principles, concepts, theories and standards of scientific/technical field.
• Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidances and requirements.

• Excellent written/oral communication skills and attention to detail
• Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;
• Proficient time and project management skills.
• Self-starter with a drive and perseverance to achieve results