Head of Medical Writing

Location
Cambridge, MA, United States
Posted
Mar 27, 2021
Ref
R95
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

How you will Achieve More with Intellia:

Reporting to the Vice President, Development Operations, you will be responsible for creating, authoring, and leading 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.

In this opportunity, you will collaborate with and actively participate 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, you may partner with Key Opinion Leaders (KOLs), Contract Research Organizations (CROs), co-development partners

Responsibilities:
  • Sound understanding of clinical research, drug development, required regulatory guidance's
  • Development and management of global data transparency plans for each development program, which may include study participants, patients, HCPs, and the public.
  • Data transparency planning experiences, including
    • Ensure compliance with disclosure requirements on public websites
    • Share data with both study subjects and researchers (PhRMA/EFPIA commitments)
    • Maintain alignment with journal publications
  • 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
  • Project manage, strategic design, planning, team input and reviews
  • Perform literature-based research to support writing activities
  • Participation in industry wide initiatives, both nationally and globally

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
  • Experienced in resource planning and management experience with virtual teams
  • Takes 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


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.