Reporting to the Vice President, Development Operations

Create, author, and lead the management of key documents for programs, regulatory filings, clinical studies and external publications, such as clinical protocols (and amendments), clinical study reports, subject consent forms, investigator’s brochures, product dossiers, integrated safety and efficacy summaries, and other documents required for regulatory submissions, abstracts, posters and manuscripts. 

Collaborates with and active participation in cross functional teams, such as:  clinical operations, data sciences, regulatory affairs, medical, biostatistics, pharmacovigilance/safety, new product planning, program management, corporate communications.  In addition, may partner with Key Opinion Leaders (KOLs), Contract Research Organizations (CROs), co-development partners

Responsible for development and managing global data transparency plans for each development program, which may include study participants, patients, HCPs, and the public.

Responsibilities:

• Sound understanding of clinical research, drug development, required regulatory guidance’s
• Data transparency planning experiences, including
  • Compliance with disclosure requirements on public websites
  • Data sharing with study subjects
  • Data sharing with researchers (PhRMA/EFPIA commitments)
  • Alignment with journal publications
• Able to evaluate, analyze, and interpret the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, scientific rigor
• Contribute to statistical output plan concerning organization and table layout for a specific document
• Take ownership of a given assignment, solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members
  • Experienced in resource planning and management experience with virtual teams
  • Project manages strategic design, planning, team input and reviews
• Perform literature-based research to support writing activities
• Participation in industry wide, national and global initiatives

Qualifications:

• 5-10 years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
• A Bachelors, Masters, PharmD or Ph.D. in a life science of health discipline
• A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements Demonstrated understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.) and experience as a lead author with such documents
• Proficiency with templates and style guides
• Excellent communication skills, both oral and written
• Strong interpersonal, negotiation, verbal, and written communication skills
• Strong organizational and meeting skills and attention to detail

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.