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 .
We have the need for a highly collaborative, experienced Manager of Medical Writing Operations (QC/Editing) to join our team based in Waltham, MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure adherence to GCP, ICH guidelines, and Alkermes SOPs.
The Medical Writing Operations manager 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 per MW SOPs and internal procedures. The Medical Writing Manager will provide oversight for compilation and accuracy of CSR appendices and will ensure templates are applied consistently, and writing style is consistent across documents (within and across programs). The Manager will also be responsible for basic copyediting (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, Knowledge Management Services, Clinical QA, and CROs/vendors (as needed)
* Coordinate with various functional areas in Clinical Development and Medical Affairs, Regulatory, Clinical Quality Assurance, Knowledge management Services, and Biostatistics, in preparation of clinical and regulatory documents
* Act as Lead Medical Writer at Project level in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
* Take a lead role in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices
* Represent Medical Writing on clinical teams
* Plan and coordinate work with in-house Medical Writers and outside CROs to ensure quality deliverables within assigned time frames
* Mentor/supervise junior Medical Writers
* Experience with Microsoft Word, Adobe Acrobat professional, and EndNote reference library
* NDA experience with active contribution in QC of summary documents is a plus
* Excellent interpersonal and communication skills
* Flexibility/adaptability to work in a fast-paced and dynamic environment
* Expertise with Word and Adobe Acrobat is a must
* Experience in managing people and projects and vendor oversight
* Experience in working with cross-functional teams and engage/escalate to ensure quality deliverables in planned time frame
* 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
MINIMUM EDUCATION AND EXPERIENCE:
* Candidates should have a bachelor's degree, preferably in a biological science, and direct experience working in clinical drug development or related area
* 5+ years of industry experience as Medical Writer/Clinical Editor/QC specialist
* Experience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas is a plus
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.
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