Waltham, MA, United States
Quality, Biotech, Sciences
Position: QC Associate- Medical Writing
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com
The Medical Writing QC Specialist will be responsible for quality review of all Medical Writing deliverables to ensure accuracy and consistency of message. This includes a check for number accuracy against source documents and for consistency within given document and between associated documents (for example, making sure the details of a protocol align with the SAP and IB, or making sure the messaging and details in a briefing package align with the messaging and details in applicable protocols, study reports, IBs, other regulatory submission documents, etc.) per MW SOPs and internal procedures. The Medical Writing QC Specialist will also be responsible for compilation oversight and accuracy of CSR appendices and will ensure templates are applied consistently, and writing style is consistent across documents (within and across programs). The Medical Writing QC Specialist will also be responsible for basic copyediting (spelling, punctuation, grammar) and technical formatting of documents.
In addition to the Medical Writing Team, this person will work closely with the Regulatory Operations group and CROs/vendors (as needed)
Candidates should have a bachelor’s degree in a biological science and direct experience working in clinical drug development.
Familiarity with ICH, GCP guidelines and associated clinical development regulations such as the eCTD and submission readiness is required.
Expertise with Word and Adobe Acrobat is a must.
The successful candidate will be focused, methodical, and detail oriented, able to discriminate substantive or critical errors from minor ones, and will be able to communicate diplomatically and function as a collaborative team member.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Website : http://www.alkermes.com
Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease.