Job: Executive Director, Medical Writing, Regeneron, Tarrytown, NY

General Information

Job title:
Executive Director, Medical Writing
Job location:
Tarrytown, NY 14627 United States

Requisition code:
Date posted:
Job type:

Career path:

Scientific Discipline:

Job Description

• Establish writing and document review standards for the department, ensuring that they are in compliance with applicable regulatory guidance and industry standards.

• Oversight of global Clinical Trial Disclosure and Data Transparency and outsourcing of medical writing activities

• Be responsible for tracking all Medical Writing documents, analyzing long-term Medical Writing staffing needs, and distributing work appropriately among department members & external consultants/vendors.

• Set the standards for department guidelines, templates, timelines and SOPs, ensuring that they are in compliance with applicable regulatory guidance and industry standards.

• Provide guidance and leadership to Medical Writing staff , providing oversight for all document creation and document creation processes, overseeing communication, resolving issues and escalating, as necessary

• Provide guidance and leadership to Clinical Trial Disclosure and Data Transparency staff, providing oversight for all disclosure and transparency activities are performed on time and development and implementation of processes, standards and training materials for Disclosure and Transparency activities

• Be responsible for the management and development of staff including: performance mgmt., recruiting, coaching and training.

• Perform annual performance reviews and ensure development plans are in place for all members of staff. Affairs.

• Maintains a list of primary healthcare practitioner/opinion leader/investigator targets and associated plans of action.

• Represent Medical Writing and Clinical Trial Disclosure and Transparency at cross-company and TA meetings.

• Drive results and outcomes for meetings; Participants look to this person for actions and decisions; Approve agendas; Articulate document strategy and timelines.

• Be able to identify the correct parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss.

• Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.

• Navigate through conflict successfully.

• Manage processes and organize priorities; Solve problems and put out fires; Foster collaboration to resolve conflict.

• Take ownership for leading, challenging, and developing Medical Writing team

Job Requirements

• Bachelor's degree (advanced degree preferred) and a minimum of 15+ years of industry experience, 10 years of medical writing experience, and 7 years of management experience.

• This individual is expected to be the subject-matter expert in the field of Medical Writing. Healthcare professional possessing therapeutic experience and/or trial recruitment experience.

• Have experience writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Investigator brochures, and Clinical Summaries, and leading multiple filings (INDINDAlBLAlMAA, etc.) in-US and ex-US.

• Understands clinical drug development process, including clinical trial design, operations and results analysis

• Strong leadership and project management skills

• Understand the general document content for each clinical document type, how the individual document types fit into a filing and feed from one to the next, and how to message appropriately across the clinical documents in a filing.

• Understand the company vision and influences and provide the appropriate leadership.

• Expected to have a good working knowledge of Access, Excel, PDF, and Project, be skilled in the use of MS WORD, and have used 1 or more EDM systems

(Job number: 3916902)