Principal Medical Writer

CSL Behring • King Of Prussia, PA • 40min ago

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 effectivecommunication

Accountable for medical writing deliverable quality and ensures adherence to departmentalprocedures / practices, and industry / international standards

Minimum Qualifications and 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 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 (https://www.csl.com/careers/your-well-being) .

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 .

R-287636

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement

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