Regulatory Writing Mgr

In this vital role, you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities.

Roles & Responsibilities:

• 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 the Global Regulatory Plan and team goals.
• May work with contract and freelance writers.
• May participate in the 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.

What we expect of you

Basic Qualifications:

• Doctorate degree OR
• Master's degree and 4 to 6 years of directly related experience OR
• Bachelor's degree and 6 to 8 years of directly related experience OR
• Diploma and 10 to 12 years of directly related experience.

Preferred Qualifications:

Functional Skills:

• Proficiency with word processing and other Microsoft Office Programs.
• Significant knowledge of scientific/technical writing and editing, and of the 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 the scientific/technical field.
• Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidances and requirements.

Soft Skills:

• 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.