Associate Director Medical Writer - Perm - Wilmington, DE
Proclinical is seeking an Associate Director Medical Writer for a role based in Wilmington, DE. This position focuses on developing clinical documents for global regulatory submissions.
Primary Responsibilities:
The successful candidate will 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. You will also mentor less experienced writers and oversee medical writing activities for multiple compounds.
Skills & 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.Ability to interact effectively with team members/leaders and senior leaders at Incyte proactively facilitating effective information exchange/communication (including problem solving and issue resolution).
The Associate Director Medical Writer's responsibilities will be:
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, in adherence with study/project timelines and corporate objectives.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) (eg, Protocols and Statistical Analysis Plans), 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.Mentors more junior medical writing staff.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com
Proclinical 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.