Director, Medical Writing - 2437

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

The Head of Medical Writing (Sr Director), Medical Writing will work collaboratively with Editas clinical development, operations,  regulatory, statistics and data management teams to produce high quality documents to support the company’s drug development programs. This role is responsible for developing and implementing processes and standards to ensure company documentation is prepared to the highest editorial standards and quality and to ensure compliance with regulatory guidance. This person will be responsible for leading a team of contract medical writers in helping the company to achieve corporate objectives. This position reports to the VP of Clinical Operations.

Key responsibilities:
Responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of a clinical program

• Advanced knowledge of IND/BLA submissions and working knowledge of and experience in document management systems
• Develop, align, coordinate, and build consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continue through study level documents to final program level deliverables (i.e., regulatory submission, preparation of clinical study reports, or publications [as requested and agreed to])
• Advise on strategic document development, ensuring adherence to regulations, ICH guidelines, and standard operating procedures (SOPs)
• Define and oversee all clinical writing activities with cross functional alignment on timing, content and stakeholders
• Leads a team of contract medical writers to ensure the delivery of on time, high-quality work
• Responsible for implementing and overseeing contract medical writing budget
• Willing to write documents
• Coordinate preparation, editing, and finalizing protocols, investigator brochures, synopses, clinical study reports, regulatory documents (BLA, annual reports, orphan drug designation applications, agency response to questions, briefing books, etc.)
• Collaborate with the clinical and scientific staff for narrative and data presentation planning, gather material for relevant documents and ensure that documents accurately reflect sources
• Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
• Ensure documentation conforms to ICH and other relevant regulatory guidelines and medical editorial boards
• Develops and implements processes and standards to ensure high quality document output and to ensure compliance with regulatory guidance.
• Hybrid position, on site 2-3 days per week
  
  

Requirements

Educational requirements:

• Master’s degree in medical-related field or life science required; (PhD) preferred

Experience and skill requirement:

• 15+ years’ experience in a medical writing capacity within drug development

• Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs
• Previous experience managing direct reports is that includes mentoring, training, and developing staff
• Thorough knowledge of clinical research concepts, practices, and FDA/EMA regulations and ICH/GCP Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
• Experience working with CROs, vendors, and relationship management. Experience interacting and communicating timeline expectations with cross functional study team members
• Expert ability to interpret internal/external business challenges and develop best practices to improve process and services
• Exceptional ability to communicate highly complex ideas, anticipate potential objections, interact with senior leaders, and apply advance negotiation skills
• Experience with electronic document management systems
• Highly proficient in the functi