Sobre esta vaga de Principal Medical Writer na CSL
The Principal Medical Writer is a key leadership position responsible for determining and driving the medical writing strategy for one or more Programs within Clinical Development.
The incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing 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 effective communication
Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards
Minimum Qualifications and Experience:
Bachelor’s degree in science related discipline with 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 processes and standards
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 effective influencing skills, able to lead without formal authority
Excellent organizational and time management skills with demonstrated ability to manage several projects simultaneously.
Ability to analyze critically and synthesize complex scientific information from a range 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
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 https://www.csl.com/careers/inclusion-and-belonging
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 https://www.csl.com/accessibility-statement.
