Nonclinical Regulatory Document and Scientific Writer

• 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.

• 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
• Basic understanding of IP, contracting terms, and provisions

• 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 the recruitment and hiring of new writers as needed

• 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
• Ability to prioritize and manage time efficiently

• 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
• 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 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

The hourly rate for this position is between $65 - $68 per hour.

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 | sunny.r@sunrisesys.com | URL: www.sunrisesys.com