Senior Principal Medical Writer
1 settimana fa
OverviewSenior Principal Medical Writer - Regulatory - Oncology - Single SponsorSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers on the customer and the patient. We collaborate to simplify and streamline work, accelerating delivery of therapies and improving lives.Discover what our 29,000 employees across 110 countries already know: work matters everywhere.ResponsibilitiesDevelop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.Participate in cross-functional process improvement initiatives.Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents.Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.Mentor more junior medical writing staff.Compensation and BenefitsSalary Range: $114,000.00 - $210,900.00. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications and competencies.Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) with company match, eligibility to participate in an Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on performance, and flexible PTO and sick time. Eligibility for paid sick time may vary by location in compliance with applicable laws.Company and CultureGet to know Syneos Health: we value diversity of thought, backgrounds, cultures, and perspectives, and strive to create a sense of belonging.Additional InformationTasks, duties, and responsibilities are not exhaustive. The Company may assign additional tasks at its sole discretion. This description is intended to comply with applicable laws and regulations. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.#J-18808-Ljbffr
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Senior Medical Writer, Oncology — Regulatory Submissions
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Milano, Italia Syneos Health A tempo pienoA leading biopharmaceutical solutions organization is seeking a Principal Medical Writer to develop regulatory documents for global submissions. This mid-senior level role involves managing medical writing projects, providing strategic direction to cross-functional teams, and ensuring high-quality document delivery in compliance with regulatory standards....
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Principal Medical Writer
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Milano, Italia Syneos Health A tempo pienoPrincipal Medical Writer – Submission Docs (2.5/2.7.2/2.7.3/2.7.4) – Oncology – Remote Based Principal Medical Writer – Submission Docs (2.5/2.7.2/2.7.3/2.7.4) – Oncology – Remote Based at Syneos Health . Syneos Health is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate...
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Senior Principal Medical Writer
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Milano, Italia Syneos Health A tempo pienoOverview Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...
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