Shire Senior Medical Writer in Lexington, Massachusetts
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
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.