Contract Medical Writer (QC)
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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 Contract Medical Writer (QC) will be responsible for quality review of all Medical Writing deliverables to ensure accuracy and consistency of message.
* Oversee 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.
* 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).
* Basic copy editing (spelling, punctuation, grammar) and technical formatting of documents.
Internal relationships: 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 bachelors 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.