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 :

Preferred Qualifications :

Functional Skills :

Soft Skills :

Skills Required

Regulatory, Medical Writing, Pharmaceutical, Word Processing, Editing, Ich