Senior Clinical Regulatory Medical Writer
Regulatory | (Remote) | Full Time
We are Translational Drug Development - TD2: 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 your medicines from preclinical development into clinical trials. Adaptive and forward-thinking, we guide your therapy through the most critical development milestones from the lab to planning your regulatory and clinical strategy. Our ultimate goal? To help patients.
The Senior Clinical Regulatory Medical Writer is responsible for the planning and preparing clinical regulatory documents, including clinical protocols, amendments, investigator’s brochures, orphan medical drug product applications, clinical study reports, annual reports, etc. within agreed upon timelines, and ensuring compliance with all associated procedures.
Serve as the technical lead for clinical regulatory medical writing projects, acting as the writing liaison to the client, while working effectively and collaboratively with other functional areas including but not limited to clinical operations, biostatistics, medical, and regulatory affairs personnel to plan, prepare and deliver high quality clinical regulatory documents.
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 that are clear, grammatically correct, technically accurate, internally consistent 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.
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.
Collaborates with program management, clinicians, clinical scientists, biostatisticians, and Pharmacokineticist to interpret study results and ensure study results, narratives, and statistical interpretations are accurately and clearly reflected in relevant documents.
Ensure that appropriate, up-to-date records are maintained in compliance with SOPs, ICH Guidance and GCP. Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
Build client relationships that result in repeat business.
Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
Identify, develop, and maintain standard operating procedures or local working guidelines and train staff, including employees and contractors, in medical writing policies or procedures.
Mentor less experienced medical writers.
Perform other related duties as assigned
- Bachelor of Science degree in a medical-related or life science field
- Masters, PharmD, or PhD strongly preferred
- Minimum 5 years medical writing experience
- Minimum 2 years of oncology experience preferred
Required Specialized/Technical Skills:
- Knowledge of GCP, ICH guidelines, and FDA regulations
- Experienced using AMA Manual of Style
- Thorough understanding of the clinical drug development process
- Advanced working knowledge of MS Office products, including Word, Excel, PowerPoint, and MS Project
- Ability to work collaboratively with team members and build excellent relationships with Sponsors and team members
- Ability to work 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.