Nonclinical Regulatory Document and Scientific Writer

Description: Job Title: Scientific Writer Translational Development
Location: Onsite/Hybrid: 50% at Giralda Farms
Hours: Mon-Fri 8am-5pm

Summary
Reporting to the Program Management Lead, 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 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. 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
Participate in recruitment and hiring of new writers as needed
Qualifications
Masters 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, 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
Ability to prioritize and manage time efficiently

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
Able to anticipate problems at project level
Proven track record of scientific approach to complex 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) develop scientific direction for assignments
Recognize cross-functional issues
Communicates within the larger organization
Develops constructive relationships across 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
Provides expert guidance to multi-disciplinary teams and senior management

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.


Our company is committed to ensuring that people with disabilities can excel 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 direct your

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