University Job Title
Scientific Writer **
Bargaining Unit**
None - Not included in the union (Yale Union Group) **
Time Type**
Full time **
Duration Type**
Regular **
Compensation Grade**
Administration & Operations **
Compensation Grade Profile**
Senior Manager; Senior Program Leader (P6) **
Wage Ranges**
Click here to see our Wage Ranges **
Searchable Job Family**
Administration, Clinical, Miscellaneous, Research Res Support, Research/Support **
Total # of hours to be worked:**
37.5 **
Work Week**
Standard (M-F equal number of hours per day) **
Work Location**
Medical School Campus **
Worksite Address**
221 Whitney Ave
New Haven, CT 06511 **
Work Model**
Remote **
Position Focus**
This is a remote position.
Reporting to the Medical Director of Yale Cancer Center’s Clinical Trial Office, the scientific writer collaborates with members of cross-functional teams to prepare high-quality scientific writing and editing support to YCC investigators who are developing: Clinical research documents including, but not limited to clinical protocols, informed consent forms, investigational brochures Applications for clinical trial support including, but not limited to Letters of Intent Study reports including but not limited to scientific manuscripts, meeting abstracts, final study summaries, posters, slide sets. **
Essential Duties**
- Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
- Participates in planning, including development of strategic plans to support funding applications for research protocols, including drafting Letters of Intent (LOI)
- Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
- Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
- Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
- Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
- Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- Works closely with the study team to reach consensus on timelines for deliverables
- Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
- Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
- Manages all aspects of outsourced or internal CSR production and ensures project delivery
- Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
- Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
- Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
- Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
- Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
- Align with department management to set strategy for meeting department goals
- Other duties as assigned
Required Education And Experience
Doctoral Degree or Bachelor’s degree +6 years or Master’s Degree +2 years of relevant work experience with at least two years involving medical writing. **
Required Skill/Ability 1**
Extensive knowledge, understanding, writing & editing demonstrated ability in at least one of the following areas: clinical trial protocol dev; investigational new drug applications inc. general investigational plan, investigator’s brochure, CMC information, pharmacology & toxicology information sections; manuscript prep for biomedical research journals. **
Required Skill/Ability 2**
Advanced understanding of medical and scientific terminology, especially as it relates to oncology and biomedical basic and clinical research. Knows and understands the applicability of the Code of Federal Regulations and guidance documents from the FDA, OHRP, and ICH on research with human subjects. **
Required Skill/Ability 3**
High level proficiency with Microsoft Word; proficient with Microsoft Excel and Powerpoint and with Adobe Acrobat. **
Required Skill/Ability 4**
Excellent organizational, communication, and interpersonal skills, both oral and written. Demonstrated problem solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external customers. Ability to identify issues and generate solutions or request appropriate intervention by management. **
Required Skill/Ability 5**
Proven ability to work in a fast paced, demanding environment and adapt to changing priorities without supervision. Demonstrated ability to manage the individual components of a single project and the ability to manage simultaneous projects. **
Preferred Education, Experience And Skills**
Graduate degree (master’s or doctoral) preferred; PhD in a health-related field or PharmD. At least five years of experience with technical, scientific, or medical writing in an academic medical environment, a pharmaceutical environment, a biotechnology company environment, or the equivalent. Writing in one or more of the oncology or rare diseases therapeutic areas. **
Weekend Hours Required?**
Occasional **
Evening Hours Required?**
Occasional **
Drug Screen**
No **
Health Screening**
No **
Background Check Requirements**
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website. **
COVID-19 Vaccine Requirement**
Required
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines **
Posting Disclaimer**
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments. **
EEO Statement**
University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.
Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA). **
Note**
Yale University is a tobacco-free campus
