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.
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