Senior Medical Communications Writer - Contract
Regulatory | (Remote) | Contract
We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.
The Contract Senior Medical Communications Writer is responsible for planning and preparing documents that convey scientific data and clinical results in a clear and concise manner, including manuscripts, posters, abstracts, etc. within agreed upon timelines, and ensuring compliance with all associated procedures.
Serve as the communications lead for medical writing projects, acting as the writing liaison to the client, while working independently to research and produce content and collaboratively with the Sponsor, investigators, and team members to plan, prepare and deliver high quality documents on a strict deadline.
Schedule and lead document-related meetings, including pre-planning, developing agenda topics, generating minutes, and appropriate follow-up after meetings to keep the team engaged and to keep the project on track with Sponsor expectations.
Prepare, edit, and finalize documents and scientific materials that are clear, grammatically correct, scientifically as well as medically accurate, and that adhere to agreed-upon standards. Ensure a consistent style of presentation of documents to maintain quality and ease of review.
Work with study teams to develop project timelines, including review cycles, proactively manage work to meet review schedules, and follow up with the study team to ensure the overall client timelines are met or notifies client as soon as possible of any delays.
Perform background research and manage document review processes to ensure that conflicting or ambiguous comments are clarified and addressed. Identify and propose solutions to resolve issues and questions that arise during the writing and review process.
Ensure that appropriate, up-to-date records are maintained in compliance with SOP’s and GCP.
Build client relationships that result in repeat business.
Perform peer review of manuscripts and other documents written by other medical writers.
Mentor less experienced writers.
Perform other related duties as assigned
- This position requires a Master of Science degree in a medical-related or life science field. PharmD, or PhD strongly preferred.
- At least 5 years medical writing experience in a medical communications or academic environment.
Required Specialized/Technical Skills:
- Knowledge of GCP, ICH guidelines, and FDA regulations, as well as the AMA Manual of Style
- Thorough understanding of the clinical drug development process
- Advanced working knowledge of MS Office products, including Word, Excel, and PowerPoint
- Ability to work collaboratively with team members and build excellent relationships with Sponsors and team members
- Ability to conduct research independently with minimal supervision
- Excellent organizational, interpersonal, communication (verbal and written) skills with impeccable attention to detail.
- Able to work under tight timelines, with a high degree of accuracy and on multiple programs at once.
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.