Senior Medical Writer
hace 1 semana
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. technical and therapeutic area training; 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 (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) (eg, Protocols and Statistical Analysis Plans), as appropriate. Participate in defining and writing standard operating procedures and best practices for an 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. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Further, nothing contained herein should be construed to create an employment contract. The Company is 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 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 (eg, 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. Reports to a Director of Medical Writing or above. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
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Senior Medical Writer
hace 2 semanas
Madrid, España Wunderman Thompson A tiempo completoUna agencia de comunicación global busca un/a Senior Medical Writer en Madrid para diseñar estrategias de Medical Education. El candidato ideal tendrá al menos 5 años de experiencia en redacción médica, una formación universitaria en ciencias de la salud y un inglés fluido. Se valora la capacidad de trabajar en equipo, proactividad y curiosidad por...
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Senior Medical Writer
hace 2 semanas
madrid, España Wunderman Thompson A tiempo completoUna agencia de comunicación global busca un/a Senior Medical Writer en Madrid para diseñar estrategias de Medical Education. El candidato ideal tendrá al menos 5 años de experiencia en redacción médica, una formación universitaria en ciencias de la salud y un inglés fluido. Se valora la capacidad de trabajar en equipo, proactividad y curiosidad por...
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Senior Medical Writer
hace 1 semana
Madrid, España TFS HealthScience A tiempo completo**About this role** TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions. Senior Medical Writer is part of the...
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Medical Writer
hace 2 semanas
Madrid, España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to bringing the cancer treatments of the future to the patients of today.TRIO is seeking a Medical Writer to join our Medical Writing and Training...
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Medical Writer
hace 1 semana
Madrid, España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to bringing the cancer treatments of the future to the patients of today. TRIO is seeking a Medical Writer to join our Medical Writing and Training...
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Medical Writer
hace 2 semanas
Madrid, España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to bringing the cancer treatments of the future to the patients of today. TRIO is seeking a Medical Writer to join our Medical Writing and Training...
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Medical Writer
hace 2 semanas
madrid, España TRIO - Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to bringing the cancer treatments of the future to the patients of today. TRIO is seeking a Medical Writer to join our Medical Writing and Training...
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Medical Writer
hace 1 semana
madrid, España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to bringing the cancer treatments of the future to the patients of today. TRIO is seeking a Medical Writer to join our Medical Writing and Training...
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Medical Writer Remote
hace 7 días
Madrid, España Hays A tiempo completoHays is collaborating with one of the leading companies in the pharmaceutical sector , . They create innovative medicines for people and animals, adding value through innovation for all three business areas: human pharmaceuticals, animal health, and contract manufacturing of biopharmaceuticals. We are looking for aScientific Medical Writer.The Scientific...
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Remote Senior Regulatory Medical Writer
hace 2 semanas
madrid, España Syneos Health A tiempo completoA leading biopharmaceutical solutions organization is seeking a Sr Regulatory Medical Writer to oversee and produce high-quality medical documents. This full-time remote role involves collaboration with clients and cross-department coordination to ensure regulatory compliance. The ideal candidate will have an advanced degree in life sciences, proven medical...
