Associate Director, Principal Medical Writer II

Incyte Corporation•Remote Location, UNAVAILABLE

12d

About The Position

The Associate Director, Principal Medical Writer II develops clinical documents for global regulatory submissions and provides strategic direction to cross-functional project teams with minimal oversight. The role ensures clinical documents—including Investigators' Brochures, Clinical Study Reports, and marketing authorization submission documents—present data-driven clinical messages accurately and consistently, in line with program goals and regulatory requirements. The position writes documents or leads other writers to deliver high-quality work on time, with scientific rigor, logical organization, and accurate data presentation and interpretation. It oversees medical writing activities for multiple compounds, serves as lead writer for individual summary documents, applies a broad understanding of clinical research processes and global regulatory document standards, and mentors less experienced writers. The role reports to a Director of Medical Writing or above.

Requirements

Bachelor's degree or equivalent experience.
Strong verbal, written, and interpersonal communication skills for effective teamwork.
Proficiency in MS Word.
Experience with an electronic document management system and templates.
Excellent project management skills, including an in-depth understanding of clinical timelines at study and submission levels.
Working knowledge of the roles of other functional areas and interdependencies among groups.
Ability to understand and interpret clinical and scientific data with minimal oversight and define data presentation to support key messages developed by the clinical team.
Ability to interact effectively with colleagues and leaders at all levels, proactively facilitate information exchange and communication, and support problem solving and issue resolution.
Demonstrated ability to independently lead development, review, and approval of clinical documents and identify new or unique document types that may require a different approach.

Nice To Haves

Advanced degree in a relevant scientific, clinical, or regulatory field, or equivalent experience.
Knowledge of therapeutic areas across all phases of clinical development.

Responsibilities

Lead or participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents.
Provide guidance and support to less experienced medical writing staff.
Lead or participate in cross-functional process improvement initiatives.
Review other documents associated with assigned projects, such as protocols and statistical analysis plans, as appropriate.
Participate in cross-functional meetings and provide input on medical writing deliverables, timelines, and processes needed to complete regulatory documents.
Lead, manage, and coordinate internal and external clinical medical writing activities for the preparation, compilation, and global submission of applications for assigned programs or compounds.
Develop regulatory documents for global regulatory agencies in accordance with ICH and other global guidelines, standards, processes, and applicable Incyte authoring standards, while meeting study and project timelines and corporate objectives.
Provide strategic direction to cross-functional project teams and lead the development, review, and approval of clinical documents.
Serve as lead writer for individual summary documents and oversee medical writing activities across multiple compounds.
Mentor less experienced writers.