Senior Principal Medical Writer
il y a 2 jours
Senior Principal Medical Writer – Regulatory – Oncology – Single Sponsor Updated: October 2, 2025Location: Montrouge, 1, France Job Description Senior Principal Medical Writer – Regulatory – Oncology – Single Sponsor Responsibilities Develop 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 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. Define and write 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. Qualifications The Associate Director, Principal Medical Writer I is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross‑functional project teams with minimal oversight to ensure that clinical documents (e.g., Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data‑driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards. Mentors less experienced writers. Reports to a Director of Medical Writing or above. Benefits & Compensation Salary Range: $114,000.00 – $210,900.00Benefits may include a company car or car allowance, health benefits (medical, dental, vision), company match 401(k), eligibility to participate in employee stock purchase plan, eligibility to earn commissions/bonus, and flexible paid time off (PTO) and sick time. Eligible for paid sick time per applicable state and municipal regulations. EEO Statement We are committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company is also committed to compliance with the EU Equality Directive and is committed to equal employment opportunity for all employees and applicants. #J-18808-Ljbffr
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Senior Principal Regulatory Oncology Medical Writer
il y a 2 jours
Montrouge, France Syneos Health, Inc. Temps pleinA leading healthcare solutions company seeks a Senior Principal Medical Writer to develop regulatory documents for global submission. The ideal candidate has extensive experience in clinical writing, project management, and mentoring junior staff. Responsibilities include overseeing medical writing projects, collaborating with cross-functional teams, and...
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Principal Medical Writer: Regulatory Submissions Lead
il y a 2 jours
Montrouge, France Syneos Health, Inc. Temps pleinA leading biopharmaceutical solutions organization is seeking a Principal Medical Writer to lead the creation of regulatory submission documents in Montrouge, France. The ideal candidate will have a Bachelor's degree and 3-5 years of relevant writing experience, with a strong grasp of FDA and ICH regulations. Responsibilities include managing medical writing...
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Principal Medical Writer
il y a 2 jours
Montrouge, France Syneos Health, Inc. Temps pleinPrincipal Medical Writer - Regulatory Submission Documents Updated: December 3, 2025Location: Montrouge, 1, FranceJob ID: 25100455-OTHLOC-3527-2DR Description Principal Medical Writer - Regulatory Submission Documents Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate...
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Senior Principle Medical Writer
il y a 6 jours
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Principal Medical Writer
il y a 1 semaine
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