Director, Medical Writing

Location
Emeryville, CA
Posted
Jul 26, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.  

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.  

GENERAL SUMMARY:  
The Director, Medical Writing is the lead medical writer for the group and will manage the function; 75% will manager your own writing and 25% will manage the writing of others.  This role will be responsible for managing all external medical writing vendors and will manage systems and procedures for document writing.  Accountable for overall process including SOPs, review function and approvals with cross functional groups including Regulatory Affairs.  Manages the overall operations of a team or major project and implements this through effective leadership. The Director provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. The Director applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing department activities with those of other departments.
Responsibilities:
  • Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on program objective
  • Proactively anticipate risks, solve complex problems, and seek out and implement process improvements
  • Independently prepare clinical regulatory documents, including protocols, study reports, investigator’s brochures, and sections of regulatory submission
  • Provide medical writing input for study designs and statistical analysis plans
  • Thoroughly analyze and critically interpret data to determine the best approach to composing each document
  • Provide expert-level input to cross-functional teams that work on standard operating procedures, process improvements, and integration of new tools and technologies
  • Identify new technologies and initiatives related to the preparation of clinical documents, provide well-informed recommendations, and facilitate integration into department processes

Qualifications:
  • Bachelors degree and strong relevant work experience required
  • Experience:
  • 5+ years experience heavy medical writing in an in-house role within the Biotech or similar industry
  • Experience writing clinical regulatory documents
  • Gene therapy experience and/or rare disease therapeutic areas a plus but not required
  • Skills:
  • Ability to analyze, interpret, and summarize moderately complex data
  • Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
  • Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools.
  • Superior written and verbal communication skills
  • Physical Requirements of the Role:  
  • Sitting for long periods of time using a computer
  • Adhere to 4DMT COVID protocols and policy 
  • During the current COVID-19 pandemic, the ability to work remotely until it is safe to return to the worksite and work onsite once 4DMT deems it safe to return. 

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities