Principal Medical Writer

Key Responsibilities:

• Leads development and authoring of program-level and study-specific regulatory documents, including protocols, protocol amendments, Investigator’s Brochures, clinical study reports, sample informed consent forms, briefing documents, and other documents needed to support regulatory interactions and filings.
• Leads development and authoring of publications, including manuscripts for peer-reviewed journals, and abstracts, oral presentations, and posters presentations for medical/scientific congresses and medical society meetings in collaboration with internal clinical study teams and external researchers and/or scientists.
• Conducts peer-review of medical writing deliverables to ensure consistency, accuracy, and clarity of all documents.
• Collaborates with Biometrics and other functional areas to provide strategic guidance in developing statistical outputs required for a variety of clinical regulatory documents and publications.
• Collaborate with Biometrics In the development of case report forms and participate in the review of statistical analysis plans and data outputs.
• Serves as the functional area representative on clinical study teams and advises teams on content and format requirements for documents.
• Adheres to established regulatory standards including, but not limited to, ICH and FDA guidelines, company standard operating procedures (SOPs), work practices and approved templates.
• Assists in the development of SOPs and work practices.
• Develops departmental infrastructure, process documents, templates, and trackers in collaboration with other functional areas.
• Ensures regular and proactive communication among department staff. Monitors, tracks and reports program status to key stakeholders including senior management.
• Actively works to foster an environment of effective and collaborative working relationships amongst employees, management, and external partners.

Education and Experience:

• MS/MA or higher advanced degree with a minimum of 8 years’ related experience or an equivalent combination of education and experience.

Skills and Abilities:

• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
• Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
• Demonstrated high level of integrity and ethics.
• Solid understanding of scientific methods, science, and medical terminology in the area of oncology. Knowledge in the fields of autoimmune diseases and neurology, an asset.
•    Previous experience preparing submissions for oncology drugs using antibodies and antibody-drug conjugates.
• Pharmaceutical research and development experience beyond medical writing.
• Experience performing literature searches and preparing grant applications, abstracts, manuscripts, annual reports, and press releases.
• Technical expertise in nonclinical and clinical oncology studies.
• Exceptional oral and written communications skills and the ability to organize and present complex material clearly, concisely, and effectively.
• Extensive knowledge of English grammar.
• High standard for quality, excellent attention to detail and a methodical, diligent approach to proofreading, ensuring consistency in style, grammar, and punctuation.
• Experience and skill in document layout and formatting.
• Solid understanding of FDA and ICH regulations and guidelines.
• Proficiency with MS Office, Visio, and Adobe Acrobat.
• Ability to travel, as required (up to 20%).