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MANAGER, MEDICAL WRITING
Job Title: MANAGER, MEDICAL WRITING
Job Code: 1463
FLSA: E
Job Level: 75
Revised Date: 03/01/2022
Job Family: JF 28
Occupational Summary
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; hiring medical writers and editors; and managing work of 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.
Work Performed
Hire and allocate Medical Writing 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
Required Qualifications at this Level
Education/Training
Master's degree in a medical or life science, medical or technical writing, or other related field (Advanced degree preferred: M.D., Phar.D., Ph.D.)
Experience
Seven years medical writing experience in pharmaceutical, biotechnology, or other clinical research environment
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
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
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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.
