Senior Director, Medical Writing

Description

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Senior Vice President of Regulatory Affairs, the Senior Director, Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines.
 

This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities (including, but not limited to):

• Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals
• Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization
• Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents
• Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials
• Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines
• Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices
• Represent Medical Writing and provide medical writing expertise on cross-functional teams
• Develop detailed timelines for document development in line with company goals and SOPs
• Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator’s Brochures [IBs], and Module 2 summaries of registration dossiers
• Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables)
• Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable
• Coordinate with the Regulatory Operations team to publish documents that meet eSubmission-ready standards
• Collaborate with Biostatistics to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates
• Collaborate effectively across Viridian and with Viridian partner companies and external vendors, as applicable
• Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines
• Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC)

Requirements

• BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred
• Strong attention to detail
• Success in managing resources (internal, external, or hybrid)
• Prior direct experience leading medical writing teams responsible for global marketing authorization applications
• Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle
• Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines.
• Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
• Excellent t