Principal Medical Writer

CSL Vifor; King of Prussia (PA); On-site; USD 140,000 - 190,000; Full time

Job summary

CSL Vifor in King of Prussia, PA, seeks a Principal Medical Writer to lead the medical writing strategy for one or more clinical programs, ensuring high quality, strategically aligned deliverables for regulatory submissions and safety reviews. You will guide messaging across programs and contribute to development and submission plans.

The role requires advanced English writing, strong communication and presentation skills, and a proven track record of leading complex regulatory writing projects

Qualifications

• Bachelor’s degree in science related discipline with 5+ years of medical writing experience in biopharmaceuticals or CRO
• Post-graduate qualifications desired (PhD or MD preferred)
• Competencies include understanding regulatory requirements across stages, and ability to lead complex regulatory writing projects
• Excellent written, verbal and presentation skills
• Proven ability to lead cross-functional, multicultural teams

Responsibilities

• 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 adherence to procedures and standards

Skills

Medical writing

Cross-functional collaboration

Verbal and written communication

Presentation skills

Time management

Education

Bachelor’s degree in science

PhD or MD preferred

Tools

MS Office

CTD format

Job description

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 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.

• Exxcellent understanding of ICH-GCP.

• Detail-oriented.