Director, Medical Writing

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 Director, Medical Writing, the Director, Medical Writing will have responsibility for overseeing the delivery of a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. The 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 Director must have a strong understanding of drug development, clinical research concepts, and data interpretation and presentation. The Director may participate in the selection of and will oversee the operation of external vendors, and may eventually manage internal resources in this aim. The Director will participate in 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 may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

Responsibilities (including, but not limited to)

• Independently author and oversee external / internal resources on the authorship of eSubmission ready clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study reports, investigator’s brochures, Module 2 summaries of registration dossiers, and clinical study protocols.
• Represent Medical Writing and provide medical writing expertise on cross-functional teams.
• Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices.
• Develop detailed timelines for document development in line with company goals and SOPs.
• Manage multiple rounds of team review through document finalization (i.e., distribute documents for review; consolidate and resolve reviewer comments; lead efficient cross-functional review roundtables).
• Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control 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 with Clinical Development to review protocols and amendments to ensure that the documents are clear, well written, and consistent with the template, internal and external guidance, and program-specific conventions.
• 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.
• Participate in the ongoing development of processes, initiatives, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH / GCP / eCTD guidelines.
• Participate in the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization.
• Participate in the management of ongoing operations of high performing external vendors.
• Participate in the maintenance of a long-term project forecast and resource plan to deliver all the documents required to advance company goals. Support medical writing and other cross-functional colleagues as necessary (e.g., document review, format, and QC).

Qualifications

Benefits

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.

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