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Senior Medical Writer

CSL Behring

This is a Full-time position in KNG OF PRUSSA, PA posted February 16, 2021.

With operations in 35+ nations and ~ 27,000 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 operatesCSL 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!

• Provides leadership to the cross-functional clinical program team, and drives the provision of medical writing services to a clinical program.
• Coordinates and builds functionally aligned, consistent information and messages across all individual documents within a clinical program, including clinical development plans, study-level documents and program-level deliverables (e.g., regulatory submissions and primary publications).
• Understands where all intended messages will be located across individual documents within a clinical program e.g., clinical development plans, submissions, briefing books, responses to Health Authority questions).
• Leads the development and maintenance of medical writing SOPs and best practices.

• Bachelor degree, or equivalent, in Science related discipline.
• Post-graduate qualifications desired (PhD or MD preferred).
• 5+ years of medical writing experience within the biopharmaceutical industry or contract research organization.
• 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.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Expert MS Office skills

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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