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 s cience 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 settin g.
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.
E xcellent understanding of ICH-GCP .
Detail-oriented .
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