Medical Writing Leader
il y a 2 semaines
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium. We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’. For our Galapagos organisation we are looking for a Medical Writing Leader - any location (remote job - contractor 6 month) Scope of the job The Medical Writing Leader (MWL) is anexpert in the writing of clinical documents (e.g. Clinical Study Protocol,Clinical Study Report, Briefing Book, Investigator’s Brochure, responses toquestions from Authorities) and support the Clinical Study Team (CST) and the Project Team (PT) in the development of these documents. Your role Accountabilities related to compounds/studies: support the Clinical Study Team (CST) and the Project Team (PT) in the development of clinical documents. Actively participate in CST and other strategic meetings (when relevant), as Medical Writing representative, and closely interact with Medical, Regulatory, Biostatistics, Clinical Operations, and other functional representatives. Organize kick-off and review meetings for the clinical documents and ensure meeting minutes are documented. Write Clinical Study Reports, Clinical Study Protocols and amendments, Pediatric Investigational Plan, Clinical Overviews, and Clinical Summaries with the CST and present these documents to the Governance Reviewers, when applicable. Provide scientific and writing expertise during the development of clinical documents and ensure that these documents meet all Galapagos standards and regulatory requirements. Supervise timelines, meetings, and overall quality of the clinical document. Write the Investigator’s Brochures, in close collaboration with the section owners and the nonclinical writer(s). Support the writing of study outlines and study concepts. Write Scientific Advice, Briefing Books, and responses to questions from Authorities, in close collaboration with Regulatory. Act as first point of contact for the external medical writer, in case of outsourcing. Provide sufficient background information and instructions to the external medical writer. Accountabilities not related to compounds/studies Actively participate in Medical Writing and Biometrics team meetings. Adhere to existing Policies and Procedures and ensure timely completion of relevant training. Interact with Quality & Compliance department to follow up on audit and inspection reports and assigned Corrective Action/Preventive Action plans in timely manner; participate in audits and inspections where needed. Lead or contribute to Process Improvement initiatives as required. Adhere to existing Policies and Procedures and ensure timely completion of relevant training. Train and supervise Associate Medical Writers and/or Medical Writers, when applicable. Support the writing and/or coordination of procedural documents.
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il y a 7 jours
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il y a 2 semaines
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