Senior Director Medical Writing

Employment Type

: Full-Time

Industry

: Miscellaneous



With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Responsibilities• Responsible for the provision of medical writing services to support the clinical development, clinical safety and regulatory requirements of our clinical programs. Includes forecasting, budgeting, resource planning and resource allocation.• Accountable for the efficient preparation and delivery of high-quality, strategically aligned medical writing deliverables including the provision of a consistent product messaging strategy• Responsible for the establishment of a messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysingproposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.• Provides strategic leadership and managerial oversight for the global department.QualificationsThe Senior Director fills all medical writing and clinical publishing needs of clinical research, including, but not limited to, the development of protocols, study reports, investigator’s brochures, primary publications, and submission documents. The Senior Director also provides strategic leadership and managerial oversight for the global department. He or she will be responsible for the quality of deliverables, including the provision of a consistent product messaging strategy, which is proper for the target audience.Main Responsibilities Creates and maintains a therapeutic area (TA)-aligned Medical Writing structure, providing one medical writing leader for each TA, and nurturing relationships and communication to core Therapeutic Area Leadership Team members.Hires, onboards, coaches, trains and mentors staffEstablishes effective medical writing processes, which includes design of best practices, SOPs, templates, work instructions, style and content guides to ensure efficient preparation of high-quality medical writing deliverables.Defines and tracks timeliness and quality metrics, based on consensus and agreement with all stakeholders. Defends time frame metrics in order to guarantee quality of deliverables; trains stakeholders in MW processes as appropriate; tracks metrics over time. Develops and implements workforce planning and an outsourcing strategyAccountable for the Medical Writing forecasting and budgetingAccountable for the quality of medical writing deliverables at each stage of document development (ie, medical writing, quality control review, and clinical publishing).Interacts with Regulatory Strategy, and ensures the provision of the clinical contents of Health Authority briefing booksResponsible for university outreach and internship programs in order to create a talent pipeline that is sustainable in the future.Monitors the field of modern medical writing systems and processes and solutions through survey of relevant literature, attendance at meetings, use of external networks, and internal engagement with functions and special interest groups that are relevant to medical writing (such as automated narrative creation; natural language processing)Position QualificationsEducationBachelor Degree RequiredPost-graduate qualifications desired (PhD or MD preferred)Experience12+ years of medical writing experience within the biopharmaceutical industry or contract research organization.At least 5 years experience in supervisory role.Comprehensive understanding of medical writing for clinical development, including the documents required at each stage and their associated regulatory requirements.Comprehensive understanding of medical writing processes, standards and issues.CapabilitiesWorker Type:EmployeeWorker Sub Type:Regular Full time

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