Technical Skills In-depth understanding of hematological malignancies or solid tumors or Neuroscience disorders especially the clinical landscape, evolving therapy, competitive scenarios Strong understanding of clinical, translational and mechanistic data with Client assets and Client agents Strong background in writing and in communication strategy development, disease and or brand planning, regulatory documents preparation for in-line and late-stage development compounds in disease areas, preferably in hematology Familiarity and working knowledge of CARA or other documentation systems Understanding of late-stage drug and translational development processes Proven ability to work with global disease teams to develop strategies to support life cycle management efforts tailored to regional markets (i.e, US, EU, CAN) Strong verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, disease strategies, mechanism slides, regulatory submissions, strategic communications, literature/market/pt segment analyses Ability to synthesize complex scientific and business problems into strategy and tactics Basic understanding of IP, contracting terms and provisions Responsibilities Ensure timely delivery for the TD writing book of work such as pre-clinical reports, and Translational biomarker reports across areas of focus (eg, multiple myeloma, lymphoma, myeloid, erythroid disorders) In conjunction with TD scientists, establish annual publication goals, publication plan with priority rankings, and estimated timelines for submission, with focus to ensure all deadlines for regulatory submissions/requests are met. Routinely interact with TD Program Manager(s) on status of Heme publications Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory response and answers to regulatory queries for the TD group in conjunction with biomarker lead(s) Collaborate with TD scientists and representatives of other functions (eg, Clinical, Non-Clinical Development, Pharmacology, Drug Metabolism & Pharmacokinetics) as needed to execute publications/reports/regulatory documents Collaborate with TD Scientists and review data to determine the appropriate tabular and textual formats to ensure clarity, logic and order of presentation.