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MANAGER, REGULATORY MEDICAL WRITING, DCRI

Req ID:  8226
Date:  Oct 12, 2019
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Position Summary

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

 

Responsibilities

The Manager of Medical Writing will be accountable for all medical writing activities and will supervise a small team of regulatory and trial writing professionals from within the DCRI’s Communications department. The Manager will also be responsible for planning, writing, and editing regulatory submission documents across multiple therapeutic areas and in compliance with ICH, FDA, and global regulatory guidelines and requirements. Assignments will include allocating writing resources for DCRI clinical research projects; developing robust processes to ensure document quality and compliance; providing budgetary and resource input for DCRI business proposals; and managing work of team members and qualified contractors. Along with other medical writers in the group, the Manager will serve on clinical research project teams as lead writer in the compilation and writing of submission documents such as clinical study reports, protocols, investigator brochures; and site and patient-facing study materials such as case report form instructions, study recruitment brochures and websites, site newsletters, and study pocket cards.

 

Duties and Responsibilities:

 

  • Onboard and allocate Medical Writing resources, including contract resources, as appropriate
  • Manage performance, engagement, and utilization of regulatory and trial writing professionals within the Medical Writing team, including Senior Medical Writers, Medical Writers, Medical Editors, and Editorial Assistants in the Medical Writing group
  • As a member of clinical project teams, research, write, and manage the production of documents including but not limited to investigator brochures, clinical study reports, protocols, protocol amendments and change summaries, integrated safety/efficacy summaries, and annual safety updates
  • Confer with Sponsor representatives, DCRI Faculty/Coordinating Investigators, and Project Leaders to plan document content, timelines, and communication lines for the review/revision process
  • Coordinate and facilitate internal (DCRI) and external (Sponsor) review of assigned documents, and consolidate reviewer comments to create appropriate revisions
  • Summarize relevant clinical and scientific literature for projects and be prepared to furnish the project team/Sponsor with cited materials
  • Serve as an expert resource on the content and format of various submission documents
  • Manage project budgets and resource planning for Medical Writing deliverables
  • Manage assessment and design of work processes, including document standards for electronic Common Technical Document (eCTD) submissions, document management, and version control
  • Oversee the utilization of external consultant writers and provide for quality management for deliverables outsourced to consultants (e.g., provide  budget and timing requirements; answer questions, review written work by the consultant, gather feedback from the DCRI customers as to their satisfaction with the consultant[s])
  • Confer with members of the DCRI project team, including the Project Leader, Lead Statistician, Lead Safety Associate, and Clinical Data Management Associate, to compile necessary document content and appendices
  • Ensure that Medical Writing staff maintain and document DCRI and functional group training requirements and in conjunction with other writers in the group, provide training and direction to other less senior Medical Writers
  • Oversee design and maintenance of Word templates for regulatory documents
  • Oversee writing and maintenance of Standard Operating Procedures (SOPs) and Work Instructions for Medical Writing tasks and responsibilities.
  • Represent Medical Writing in audits of DCRI capabilities and practices conducted on behalf of  Sponsors or the FDA

 

Minimum Qualifications

Education

Advanced degree (M.D.,Ph.D.,Pharm.D) in a medical or life science, medical or technical writing, or other related field

Experience

Eight years medical writing experience in pharmaceutical, biotechnology, OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE or other clinical research environment. At least five years of the total experience should directly relate to managing resources for multiple writing projects;

 

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh