Reporting to a Medical Writing Group Lead will be responsible for medical writing activities within a project, including primary responsibility for direction, scope, and organization of specific documents in consultation with the project physician, statistician, and other team members as appropriate. Responsible for timely preparation of clinical regulatory documents such as investigators' brochures, study reports, subject narratives, integrated summaries, contributions to briefing documents, response documents, and other IND/CTA or global regulatory submission documents, ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Must be able to work effectively in a team environment and must have strong scientific interpretive, organizational, and project management skills.
• With minimal support, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators' brochures, subject narratives, Module 2 summary documents, and other IND/CTA or global regulatory submission documents.
• Actively support and participate in clinical project team(s) as as an effective representative of Medical Writing.
• Complete documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
• Manage writing, editing, QC and publishing activities for assigned projects.
• Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
• Contribute to statistical output plan concerning organization and table layout for a specific document.
• Ensure that medical writing activities are coordinated between the project team and management of the medical writing group.
Education & Experience Requirements:
• Advanced degree in a relevant scientific/clinical/regulatory field preferred
• At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
• Global regulatory submission experience
Key Skills, Abilities, and Competencies:
• Excellent writing skills.
• Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the clinical team.
• Ability to interact effectively with team leaders/members and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution)
• Knowledge of current regulatory requirements and guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents.
• Strong knowledge of MS Word, Excel, MS Project, PowerPoint, and Outlook.
• Working knowledge of template use for document creation.
• Ability to work with different template styles and types.
• Ability to prioritize multiple projects.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.