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MEDICAL WRITER, SR
Job Title: MEDICAL WRITER, SR
Job Code: 1462
FLSA: E
Job Level: 74
Revised Date: 03/01/2022
Job Family: JF 28
Occupational Summary
The Senior Medical Writer will be responsible for planning, writing, and editing submission documents across multiple therapeutic areas and in compliance with ICH, FDA, and global regulatory guidelines and requirements. Assignments will include acting as coordinator and lead writer in the compilation and writing of clinical study reports, summary sections of regulatory submissions, protocols and investigators' brochures for investigational drugs, devices, biologics and/or combination products.
Work Performed
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.
Assist with writing budgets and resource planning, and with assessment and design of work processes including document standards for electronic Common Technical Document (eCTD)submissions, document management, and version control.
Participate in the evaluation of external consultant writers as needed, and assist with project management for writing projects placed with consultant writers (e.g., provide budget and timing requirements; answer questions, review written work by the consultant).
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.
Direct the Senior Editorial Assistants work to assemble the final form of documents and associated appendices and data displays, and confirm completeness and correctness of deliverables in the required electronic or paper format.
In conjunction with other writers in Regulatory Medical Writing, provide training and direction to other less senior Medical Writers, Editors, and Editorial Assistants Assist with design and maintenance of Word templates for regulatory documents.
Assist with writing and maintenance of Standard Operating Procedures (SOPs) and Work Instructions for Regulatory Medical Writing tasks and responsibilities.
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
Five years medical writing experience in pharmaceutical, biotechnology, or other clinical research environment
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
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 provide job specific training to other Medical Writers.
Ability to work independently and to perform equally well as part of a team Able to balance multiple activities in a complex environment and to meet critical deadlines.
Strong interpersonal skills to develop and maintain positive working relationships with internal and external clients.
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.
