Lavori attuali relativi a Director, Medical Writing Lead - BOLOGNA - Alfasigma S.P.A.
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Global GI Medical Affairs Lead
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Associate director biostatistics
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Director, Medical Writing Lead
5 ore fa
OverviewAlfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan.The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.Over three years ago, we embarked on a transformative journey to becomea truly global innovative healthcare company with a leading focus in Gastrointestinal (GI) health.We have experienced remarkable growth, nearly doubling our revenues, expanding geographically, and integrating several key acquisitions.We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people capabilities.But our journey is far from completeIn fact, this is just the beginning of a bold new chapter in Alfasigma's history.We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide, and expand our reach across diverse markets.As we continue to grow, we are seeking aDirector, Medical Writing.This position can be based in Italy, but within proximity to work hybrid in either Milan, Rome, or Bologna.Scope of the roleThe Director, Medical Writing is accountable for medical writing deliverables of high visibility, high complexity, and multiple asset programs.This position operates with minimal oversightYour role:LeadershipLead team of medical writers on best practices in medical writing and regulatory submission processes, with a focus on collaboration and professional growth / innovationContribute to design of new operating model for medical writingWork closely with the reg digital team to explore and assess new technologies such as generative AI and automation to aid in efficient compilation of regulatory documentsWritingAccountable for the successful planning and implementation of all clinical and regulatory written components of global regulatory submissions across one or more development programs ensuring submissions adhere to the highest standards and are completed within timelinesProvide overall oversight, review, and approve study-level documentation required for clinical trials, submission documents and other reports intended for regulatory interactionExecute cross-functional process improvement initiatives on document standards, template development, and document processFacilitate systems and best-practices for training multidisciplinary colleagues participating in document authorshipQuality ControlProvide oversight for the quality and compliance of written components to company standards as well as regulatory requirements through oversight of the clinical quality control functionProject ManagementCollaborate with clinical and regulatory teams to establish optimal interfaces to enable efficient and thorough authorship/revision of key technical documents and oversight of diverse regulatory submission documents to support regulatory filingsPartner with other cross-functional leadership to ensure rapid identification of risks, issues, and development of potential solutions to maintain filing timelines and qualityManage and coordinate budget and resources to ensure on schedule completion of medical writing deliverables, including the identification, selection, and oversight of qualified full- or part-time medical writers, vendors, consultants, or contractorsOversee cross-functional collaborations and document review process for the medical writing teamRepresent Medical Writing as ad hoc member on Clinical Development Team (CDT) or Core Team (CT); Protocol Review Committee(PRC)Department AdministrationReview document templates and standard operating proceduresRegulatory StandardsMaintain best practices in medical writing (e.g., regulatory style guide) to enhance efficiency, quality, and compliance with industry standards.processes, including documentation standards and timelinesMaintain up-to-date knowledge of industry trends and regulatory changes and provide oversight to ensure that standards are being applied through review of documents produced by other team membersWho are you?The role requires an experienced medical writing leader with an undergraduate degree and at least 10 years, or an advanced scientific degree and at least 7 years, of relevant experience in medical writing, the pharmaceutical industry, and/or clinical research.The candidate must have deep expertise in global regulatory submissions, including IND/CTA and NDA/MAA preparation, document strategy, and lifecycle management, with proven experience leading document strategies and submission activities across one or more development programs.Experience across diverse organizational settings (pharma, biotech, and CRO) is preferred.Success in this role depends on advanced knowledge of global regulatory standards, strong leadership and people management capabilities, the ability to manage multiple complex projects under tight timelines, exceptional communication and influencing skills, and demonstrated expertise in outsourcing and resource management.The candidate must also exhibit strong problem-solving abilities, operational rigor, and native or near-native English proficiencyWhat's in it for youBe part of a growing, innovation-driven company entering new therapeutic areasWork on global, high-impact projects shaping access to cutting-edge specialty medicinesCollaborate with a diverse team of scientific and commercial expertsEnjoy a high level of autonomy and strategic influence within a global organizationOpportunities for career growth, international exposure, and leadership development#J-*****-Ljbffr
