Scientific Writer - Translational Development_26-01790
hace 4 días
Madison
Job Description Job Title: Scientific Writer – Translational Development Job ID:26-01790 Location: Onsite/Hybrid: 50% at Giralda Farms Duration: 12 Months Hours: Mon-Fri 8 am-5 pm Summary • In-depth understanding of hematological malignancies or solid tumors and neuroscience disorders, especially the clinical landscape, evolving therapy, and 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, • 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. Provide suggestions to improve flow and clarity of narrative and presentation of data, • Engage with Writers and other functions (eg, SciCom, Regulatory, Medical Affairs, Clinical, NCD) outside of TM as needed to stay current on writing SOPs, platforms, resources, and company guidelines, • Communicates regularly and prepares and makes presentations within the department and externally as required, • Master's or PhD in Hematology/Oncology/Neuroscience or related field with 6-8 years in industry or an academic setting, • Ability to manage scientific collaborations and projects, • Proven written and oral communication skills, • Ability to interpret data and craft key communication points from tables, listings, and graphs, • Ability to clearly organize presentations of data into a clear narrative, • Experience with regulatory submissions (eg, IND, NDA/sNDA) required, • Effective team building and teamwork skills with multiple functions, • Detail-oriented with the ability to identify and implement creative solutions, • Highly detail-oriented with excellent record-keeping and organizational skills, • Must be a highly flexible, results-oriented, independent self-starter who enjoys working in a fast-paced, dynamic environment, • Able to anticipate problems at the project level, • Proven track record of scientific approach to complex problem solving, • Demonstrate in-depth, science-directed, innovative thinking, • Recognizes interrelationships of facts/factors, processes, and systems, • Recognize risk and propose contingency plans, • Independently (or using collaborations) develop a scientific direction for assignments, • Recognize cross-functional issues, • Communicates within the larger organization, • Develops constructive relationships across the organization to achieve the goals of the function and the business through leadership roles on cross-functional/divisional teams, • Communicates within the larger organization and external community, • Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. Compensation: Factors which may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate]. Benefits: Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations. Contact: Sunny Rajput | | URL: Company DescriptionFounded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.