Nonclinical Regulatory Document and Scientific reputed company

reputed company: Job Title: Scientific reputed company Translational Development Location: Onsite/Hybrid: 50% at Giralda Farms Hours: Mon-Fri reputed company-5pm reputed company Reporting to the Program Management reputed company, the incumbent will be part of the late development translational group based in Giralda Farms NJ and will be responsible for writing scientific documents including biomarker reports, regulatory documents (eg, non-clinical summaries, translational portions of clinical/pharmacology summaries, briefing books, CSRs, investigator brochures) in conjunction with Translational scientists. This individual will also contribute to abstracts, posters, manuscript and other scientific communications arising from the group. 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 reputed company assets and reputed company agents Strong background in writing and in communication reputed company 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 reputed company or other documentation systems Understanding of late-stage drug and translational development processes Proven ability to work with global disease teams to reputed company 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, reputed company slides, regulatory submissions, reputed company, literature/market/pt reputed company analyses Ability to synthesize reputed company scientific and business problems into reputed company and tactics Basic understanding of IP, contracting terms and provisions Responsibilities Ensure reputed company delivery for the TD writing book of work such as reputed company-clinical reports, and Translational biomarker reports across areas of reputed company (eg, multiple myeloma, lymphoma, myeloid, erythroid disorders) In conjunction with TD scientists, establish annual publication goals, publication plan with reputed company rankings, and estimated timelines for submission, with reputed company to ensure reputed company deadlines for regulatory submissions/requests are met. Routinely reputed company 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 reputed company(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 reputed company, logic and order of presentation. reputed company suggestions to improve reputed company and reputed company of narrative and presentation of data Engage with Writers and other functions (eg, SciCom, Regulatory, Medical Affairs, Clinical, NCD) reputed company of TM as needed to stay reputed company on writing SOPs, platforms, resources, and company guidelines Communicates regularly and prepares and makes presentations reputed company the department and externally as required Participate in recruitment and hiring of new writers as needed Qualifications Masters or PhD in Hematology/Oncology/Neuroscience or reputed company field with 6-8 years in industry or an reputed company setting Ability to manage scientific collaborations and reputed company Proven written and oral communication skills Ability to interpret data and craft key communication points from tables, listings, graphs Ability to reputed company organize presentations of data into a reputed company 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 Ability to prioritize and manage time reputed company Other Attributes Highly detail-oriented with excellent record keeping and organizational skills Must be a highly flexible, results oriented, independent self-starter who enProducts working in a fast-paced dynamic environment reputed company to anticipate problems at project level Proven reputed company record of scientific approach to reputed company problem solving Demonstrate in-depth, scientific-directed, innovative thinking Recognizes interrelationships of facts/factors, processes, and systems Recognize risk and propose contingency plans Independently (or using collaborations) reputed company scientific direction for assignments Recognize cross-functional issues Communicates reputed company the larger organization Develops constructive relationships across organization to reputed company the goals of the function and the business through leadership roles on cross-functional/divisional teams Communicates reputed company the larger organization and external community Provides expert guidance to multi-disciplinary teams and senior management Around the world, we are passionate about making an reputed company 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 reputed company bring out the highest potential of reputed company of our colleagues. reputed company is committed to ensuring that people with disabilities can reputed company through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process reputed company your Custom Fields: reputed company: reputed company-Identified - Was Compensation Discussed With Candidate Value: None reputed company: reputed company-Identified - reputed company Value: None reputed company: reputed company-Identified - Comments Value: None reputed company: reputed company-Identified Resource Value: No Apply tot his job Apply To this Job