Senior CMC Regulatory 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 CMC Regulatory Writer is responsible for the planning and preparing CMC regulatory documents, including Module 3 Drug Substance and Drug Product Sections, summaries in annual reports, IND updates, end-of-phase briefing books, NDA / BLA filings etc. within agreed upon timelines, and ensuring compliance with all associated procedures.
Serve as the technical lead for CMC regulatory medical writing projects, interpreting source document data for clear regulatory document sections, while working effectively and collaboratively with other functional areas including but not limited to regulatory affairs, program management, technical experts, and other team members to plan, prepare and deliver high quality regulatory documents.
Schedule and lead document-related meetings as needed, 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.
Ensure that appropriate, up-to-date records are maintained in compliance with SOP’s and GXP.
Build client relationships that result in repeat business.
Perform quality control (QC) review of other documents written by other regulatory writers.
Mentor less experienced regulatory writers.
Perform other related duties as assigned
- This position requires a Master of Science degree in a life science field. PharmD, or PhD strongly preferred.
- At least 5 years writing experience in a regulatory environment, with 2 years of oncology experience preferred.
Required Specialized/Technical Skills:
- Knowledge of GCP, ICH guidelines, and FDA regulations, as well as the AMA Manual of Style
- Thorough understanding of the regulatory process for drug development
- 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.