Exec Director Medical Writing

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
Directs staff responsible for writing and/or editing a variety of scientific/medical documents and global Clinical Trial Disclosure and Transparency. Sets standardization requirements in compliance with regulations and ensures adherence to said requirements. Works with management to develop a strategy and set direction for the department. Tracks and prioritizes writing projects and activities related to disclosure and transparency. Works with staff to resolve project conflicts and provide document and project direction. The individual will work cross-functionally and will be a core member of the Regulatory Senior Management Team. The individual will be responsible for the budget for the function and will have line management responsibility. Represents Regulatory in all cross-departmental initiatives.

Responsibilities:

• 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
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

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.