Principal Medical Writer

The Principal Medical Writer is a key leadership position responsible for determining and driving themedical writing strategy for one or more Programs within Clinical Development. The incumbent is accountable for the efficient preparation of high quality, strategically aligned medicalwriting deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the 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 analyzing proposed 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. This role has global responsibilities, participation in global teams and interaction with regulatory agencies in multiple regions. Main Responsibilities & Accountabilities Leads the Medical Writing contributions to assigned clinical Programs Drives and develops the messaging strategy for the assigned Program(s) to ensure effectivecommunication Accountable for medical writing deliverable quality and ensures adherence to departmentalprocedures / practices, and industry / international standards Minimum Qualificationsand Experience Bachelor’s degree insciencerelated disciplinewith 5+ years of medical writing experience within the biopharmaceutical industry or contract research organization Post-graduate qualifications desired (PhD or MD preferred) Competencies 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 processesandstandards Excellent written, verbal and presentation skills Demonstrated track record in cross-functional, multicultural and international clinical trial teams. Proven effective verbal, written and presentation skills. Mastery of the English language, with a comprehensive understanding of English grammar and punctuation. Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates Prior experience with submissions in Common Technical Document (CTD) format. Proven ability to work effectively both independently or in a team setting. Proven effectiveinfluencing skills, able to lead without formal authority Excellent organizational and time management skills with demonstrated ability to manage several projects simultaneously. Ability toanalyzecritically and synthesize complex scientific information from arange of scientific disciplines and clinical therapeutic areas. Successful track record of leading complex clinical / regulatory writing projects. Excellent understanding of ICH-GCP. Detail-oriented. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit #J-18808-Ljbffr BioSpace