Senior Medical Writer

2 days ago

Wilmington, Delaware, United States Proclinical Staffing Full time
Associate Director Medical Writer

Proclinical Staffing is seeking an experienced Associate Director Medical Writer to join our team in Wilmington, DE. This role focuses on developing clinical documents for global regulatory submissions.

Key Responsibilities:
  • Provide strategic direction to cross-functional project teams, ensuring that clinical documents accurately present key data-driven messages in line with program goals and regulatory requirements.
  • Mentor less experienced writers and oversee medical writing activities for multiple compounds.
  • Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable.
  • Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for the assigned programs/compounds.
  • Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
  • Review other documents associated with the assigned project(s), as appropriate.
  • Lead or participate in cross-functional process improvement initiatives.
  • Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
Requirements:
  • Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
  • At least 7 years medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
  • Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
  • Excellent project management skills including in-depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
  • Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
  • Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired.
  • Demonstrated ability to independently lead the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach.
  • Proficient in MS Word. Experience with an electronic document management system and templates is required.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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