Associate Director, Medical Writing

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

QED Therapeutics, an affiliate within BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.

What You’ll Do

The Associate Director, Medical Writing is responsible for providing medical writing leadership to deliver clinical/regulatory documents such as clinical study reports (CSRs), clinical protocols, and investigator brochures. This position works closely with internal clinical development functional leads and other team members, senior/executive leadership, and external collaborators. The scope of documents generally ranges from pre-IND through NDA. 

Responsibilities

• Lead the development of clinical/regulatory documents and other assigned tasks within established timelines with minimal supervision
• Maintain high document quality and appropriate standards for scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
• Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives (as required), are consistent with QED and industry standards, ICH/GCP guidance, and all applicable regulatory requirements
• Serve as a point of contact and initial oversight of vendors, escalating issues to management as necessary
• Represent Medical Writing on one or more programs
• Participate in the development and implementation of process improvements and/or standards within the Medical Writing function
• Provide support for health authority transparency requirements (CTR, CSR results postings)
• Assist with the development and implementation of SOPs
• Perform other duties as requested 

Where You’ll Work

This is a U.S.-based remote role that will require quarterly, or as needed, visits to our San Francisco Office. 

Who You Are

• Ability to lead Medical Writing efforts across the organization and to develop and mentor others
• Excellent oral and written communication skills with an ability to summarize complex raw data in a concise, accurate, and easily understandable form
• Close attention to detail and a demonstrated concern for standards
• Strong project management and time management skills, along with initiative and ability to be productive with minimal supervision
• Ability to exercise discretion and show good judgment, demonstrate honesty and integrity, and foster and encourage trust-building behaviors
• Adaptable and flexible with excellent facilitation and team playing skills
• Knowledge of IND/NDA/BLA/MAA submission requirements and familiarity with the eCTD structure
• Excellent understanding of clinical development and industry regulatory requirements (ICH/FDA, GCP)
• Strong technological abilities, with proficiency in Microsoft Word, Excel, and PowerPoint. Strong command of routinely used business software/platforms (eg, Microsoft Office, Microsoft SharePoint, Adobe Acrobat, Veeva RIM, EndNote) is required
• Bachelor’s degree in a life sciences discipline; an advanced degree is preferred
• Minimum of 5 years as a medical writer in the pharmaceutical industry, including two years of management or de facto management level experience, or clear management potential 

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

• Financial Benefits:
• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities