Job Description
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The University of Miami/UHealth Department of SCCC - Protocol Development Office (PDO) has an exciting opportunity for a Full Time Scientific Writer (Medical Writer) to work Remotely.
CORE JOB SUMMARY The Scientific Writer analyzes scientific data and translates complex scientific concepts, written or oral, within a variety of fields into prose appropriate to the level of understanding of the target audience. This job also assists the Principal Investigator (PI) with the development and/or completion of scientific documents, which include the creation, formatting, proofreading, editing and finalization of scientific documents
CORE JOB FUNCTION: 1. Creates, implements, and maintains competitive application templates for grant proposals
2. Responsible for formatting, substantive copy and scientific editing, proofreading, and finalizing documents as required and requested
3. Ensures the readability, clarity, consistency, and conformance to applicable submissions requirements
4. Reviews and ensures document language is scientifically/medically correct, responsive to the document requirements, consistent, and justifiable; notifies appropriate PI or leader and suggestion alternative language, as required.
5.Communicates (telephone, email, meetings) with principal investigator and key senior leadership authors as necessary to ensure the accuracy and clarity of documents; meets both internal and sponsor submission deadlines.
6. Responsible for editing all extramurally funded proposals for grammar, readability, clarity, consistency, and conformance with all applicable requirements.
7. Works closely with presenters in the development of scientific presentations, ensuring accuracy and adherence to length and time allowed for presentation.
8. Ensures that documents conform with all applicable regulations, current guidelines, and policies; inform appropriate PI or director as required and suggest appropriate correction
9. Obtains and maintains the documentation for any required copyright transfers, conflict of interest statements, or other publisher-specific requirements.
10. Tracks progress and responds to publication queries, as appropriate
11. Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. REQUIRED CORE QUALIFICATIONS Education: Bachelor's degree in relevant field
Experience: Minimum 2 years of relevant experience
Knowledge, Skills and Attitudes: - Ability to communicate effectively in both oral and written form
- Skill in collecting, organizing and analyzing data
- Skill in completing assignments accurately and with attention to detail
- Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
- Ability to work independently and/or in a collaborative environment.
- Commitment to the University's core values.
- Proficiency in computer software (i.e. Microsoft Office).
DEPARTMENT SPECIFIC FUNCTIONS: The Scientific Writer is responsible for supporting the development of investigator-initiated trials (IITs) at the Protocol Development Office (PDO), University of Miami Sylvester Comprehensive Cancer Center (SCCC). The Scientific Writer collaborates with Principal Investigators (PIs) and the clinical research team to write study-related documents including but not limited to clinical trial protocols and informed consent documents (ICFs). The Scientific Writer is integrally involved with managing the lifecycle of clinical trials including protocol and ICF development, institutional regulatory submissions (Protocol Review and Monitoring Committee [PRMC] and Institutional Review Board [IRB]), Investigational New Drug (IND) submissions to the Food and Drug Administration (FDA), and amendments.
This position involves close collaborations with principal investigators (PIs), clinical study team members, the Clinical Research Operations and Regulatory Support (CRORS), Clinical Research Management & Support Office (CRMSO), budget analysts, site disease group (SDG) managers, contracts office, pharmaceutical company representatives, PRMC, IRB, and the FDA.
JOB FUNCTIONS: 1. Write, review, format, proofread, edit, and finalize deliverables covering all phases of clinical research including, but not limited to study protocols and informed consent forms.
2. Collaborate with PI, clinical team, statistician, and pharmaceutical company representatives to understand the scope of the project and gather relevant documents.
3. Manage institutional regulatory submissions and respond to requests for changes.
4. Collaborate with the project manager to prepare and submit FDA IND submissions as well as respond to requests for changes.
5. Plan, coordinate, and prepare for meetings and teleconferences with appropriate stakeholders.
6. Create and manage project specific deadlines.
7. Maintain regular communication with PI and clinical team to ensure completion of deliverables under strict deadlines.
8. Perform peer review of clinical study documents for other scientific and quality control (QC) documents as needed.
9. Advise project team and leadership on medical writing related issues.
10. Perform other duties assigned.
QUALIFICATIONS: Education:
A minimum of a bachelor's degree in the biomedical sciences or related discipline. •Master's degree in the biomedical sciences or related discipline preferred.
Experience:
Minimum of 3 years of relevant experience.
KNOWLEDGE, SKILLS AND ATTITUDES: 1. Experience in medical writing, oncology, and medical research strongly preferred.
2. Multi-task efficiently with minimal supervision and pivot between projects as needed.
3. Ability to communicate with professionals from a variety of backgrounds.
4. Writing sample in English may be requested as part of the application and interview process.
5. Excellent written, oral, and interpersonal communication skills.
6. Attention to detail-style, consistency, grammar, syntax, scientific accuracy.
7. Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
8. Able to produce high quality work within strict deadlines.
9. Demonstrated ability to use critical thinking to make decisions. Scientific Writer Protocol Development Office (PDO)
10. CITI certification must be obtained within first month of employment.
11. Thorough knowledge of applicable regulatory requirements and guidelines
12. Proficiency in MS Word, PowerPoint, and Outlook. Proficiency in Adobe Acrobat Pro.
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The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status: Full time
Employee Type: Staff
Pay Grade: H10 The University of Miami
Job Tags
Full time, Temporary work, Remote job, Worldwide,