Director Medical Writing

Highly Competitive
  1. Permanent
  2. Medical Writing
  3. United States
New Jersey, USA
Posting date: 01 Jul 2024
61197

Proclinical is seeking a dedicated and experienced Medical Writer for a Director position. The successful candidate will be responsible for delivering high-quality regulatory and clinical documents through cross-functional collaboration. This role is particularly suited to individuals with a strong background in medical writing, especially within the fields of ophthalmology or rare diseases.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

  • Author and coordinate clinical and regulatory documents.
  • Lead submission-level documents and manage clinical regulatory documents.
  • Ensure consistency in style, technical aspects and messaging across all documents.
  • Contribute to medical writing strategy and ensure compliance with guidelines.
  • Represent medical writing at cross-functional meetings.
  • Review regulatory documents for consistency.
  • Address document inconsistencies in collaboration with the IMVT Director.
  • Lead team review meetings and ensure timely documentation.
  • Oversee document preparation and provide status updates.
  • Train and assist other medical writers.

Key Skills and Requirements:

  • Bachelor's degree required; advanced degree preferred.
  • Proven experience in medical writing, especially in ophthalmology or rare diseases.
  • Understanding of drug development and clinical research.
  • Strong leadership and mentorship skills.
  • Experience managing medical writing teams.
  • Knowledge of FDA regulations and ICH guidelines.
  • Excellent project management, communication and interpersonal skills.
  • Fluent in English.

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz on m.hermiz@proclinical.com.



Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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