The Manager of Medical Writing in DCRI Communications will manage the Medical Writing staff in the compilation and writing of interim and final clinical study reports, protocols, investigators’ brochures, site/patient engagement materials, and other documents for submission to FDA and global regulatory agencies.
This responsibility requires the Manager to forecast Medical Writing resource needs for DCRI projects, assign Medical Writers, consultant writers and/or other staff to DCRI projects that include medical and trial writing deliverables, and ensure coordinated distribution of documents and timelines for review; to compile and incorporate reviewers’ comments; and to maintain up-to-date files of document status and content that would allow continuity of the work by other writing staff if necessary.
The Manager of Medical Writing will also function as a writer assigned to clinical project teams; as such the Manager requires knowledge of the structure and purpose of a variety of submission documents; the ability to comprehend and describe in writing concepts of medical/clinical science across multiple therapeutic areas; and knowledge of relevant guidance for documentation of investigational drugs, medical devices, biologics and combination products. This employee will assist with maintenance of templates for study reports, protocols, and other submission documents, for reference by internal and external clients.
This employee will oversee the engagement, training, and performance of the Medical Writing team, which could include Senior Medical Writers, Medical Writers, Editors, and Editorial Assistants.
Primary Tasks and Responsibilities:
Compile and draft submission documents needed for clinical research studies, including protocols, investigators’ brochures, interim and final clinical study reports, integrated safety and efficacy summaries, and other deliverable documents. 70%
Manage Medical and Trial Writing team and consultant writers; oversee training of Medical Writing staff and quality reviews; and allocate writing resources to meet DCRI project needs. 20%
Oversee development and maintenance of SOPs, document checklists, and work instructions to ensure quality of deliverables. 5%
Promote Medical Writing services to internal and external customers, and collaborate with and advise project teams regarding clinical study reports and other submission documents. 5%
The successful candidate for the position of Manager, Medical Writing, will require the following knowledge, skills and abilities at the time of hire:
Proven leadership and management skills
Strong interpersonal skills to develop and maintain positive working relationships with internal and external clients
Excellent comprehension of clinical/scientific literature, medical terminology and statistical methods
Excellent ability to interpret and describe statistical data in written reports
Ability to efficiently search, evaluate, and summarize clinical literature
Excellent attention to detail
Excellent written and verbal skills
Familiarity with the contents and purposes of regulatory submission documents, including clinical study reports
General familiarity with the clinical research process, and regulations governing clinical research globally
Intermediate to advanced knowledge of Microsoft Word, and familiarity with Adobe Acrobat, Microsoft Excel, and citation management systems such as EndNote and Zotero
Ability to develop and provide training
Able to balance multiple activities in a complex environment and to meet critical deadlines
As part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known globally for conducting groundbreaking multinational trials, managing major national patient registries, and performing landmark research. As an academic research organization, we combine the faculty expertise of practicing physicians with the full-service operational capabilities of a major contract research organization. We design and implement innovative clinical trials that advance the understanding of health and disease and inform efforts to improve the quality of care. Our experience stretches from phase I to phase IV and beyond, encompassing post-approval analyses and health economics. The breadth of our work in numerous therapeutic areas is matched by the depth of our knowledge, which we disseminate through high-impact publications and global meetings. DCRI faculty and staff have authored more than 14,000 peer-reviewed publications and have been cited in more than 619,000 scientific articles over the course of 20 years.