Director, Medical Writing

Viridian Therapeutics Inc.•Waltham, MA

57d•Hybrid

About The Position

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.

Requirements

BA/BS and 8+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred
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 technical writing and editorial skills; excellent attention to detail
Success in managing resources (internal, external, or hybrid)
Strong ability to understand and interpret medical and scientific data
Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint
Experience with automated document templates and Adobe Acrobat and EndNote
Excellent communication, interpersonal, and organizational skills
Experience working on cross-functional teams
Able to prioritize tasks, work simultaneously on multiple projects
Strong commitment to ethical standards
Proven mindset of proactive continuous improvement
Ability to travel up to 15%

Responsibilities

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 (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 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 (eg, document review, format, and QC)

Benefits

Competitive pay and stock options for all employees
Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
Fertility and mental health programs
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various mental, financial, and proactive physical health programs covered by Viridian

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