Associate Director, Medical Writing

Location
San Francisco, California
Posted
Jul 29, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country. 

To learn more, visit us at  eidostx.com/ www.bridgebio.com

Who You Are:

The Associate Director is responsible for the medical writing deliverables that support the clinical portfolio at Eidos Therapeutics. The Associate Director will prepare clinical study documents (clinical study protocols/amendments, clinical study reports, investigator’s brochure) and clinical sections of regulatory submissions. As a vital member of the Clinical Study Team, the Associate Director will have the opportunity to collaborate cross-functionally and ensure key messages are consistently aligned in preparing the clinical, regulatory document.

Responsibilities:
  • Participate in strategic discussions regarding the production and completion of high-quality clinical documents, including providing input on workload allocation, resource planning, and timeline development, as applicable
  • Participate in the development and implementation of process improvements and/or standards within the Medical Writing function
  • Serve as a point of contact and initial oversight of vendors, escalating issues to management as necessary
  • Work closely with cross-functional teams to ensure high-quality documents are completed in a timely fashion, compliant with SOPs, and consistent with industry standards, ICH/GCP guidance, and all applicable regulatory requirements
  • Collaborate with internal and external resources to ensure alignment with timelines and data communication plans
  • Ensure smooth and effective document management for clinical, regulatory documents
  • Author or provide support for clinical documents and other assigned tasks within established timelines
  • Distill large amounts of clinical and scientific data into essential elements for graphical display
  • 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, and ensure adherence to standards
  • Formulate critical messages from clinical study data with the study team(s)
  • Prepare content library for study protocols on one or more program
  • Represent Medical Writing on one or more programs
  • Liaise with other affiliates and key stakeholders as necessary to ensure appropriate coordination of activities
  • Perform other duties as requested


Education, Experience & Skills Requirements:
  • Bachelor’s degree in a life sciences discipline; an advanced degree is preferred
  • Minimum of 7 years of experience working in the biopharmaceutical industry, with a minimum of 4 years in medical writing or equivalent (experience in rare disorder, cardiorenal disorder desired)
  • Ability to exercise discretion and show good judgment, demonstrate honesty and integrity, and foster and encourage trust-building behaviors
  • Strong project management and time management skills, along with initiative and ability to be productive with minimal supervision
  • Skilled in the development of clinical, regulatory documents, including protocols, amendments, investigator’s brochures, clinical study reports
  • Strong organizational skills; experience and comfort working in a fast-paced, dynamic environment
  • Able to work autonomously and in team settings to meet aggressive goals
  • Knowledge of IND/NDA/BLA/MAA submission requirements and familiarity with the eCTD structure is desired
  • A strong understanding of FDA/ICH guidelines and GCP is required
  • Strong technological abilities, with proficiency in Microsoft Word, Excel, and PowerPoint; and strong command of routinely used business software/platforms (e.g., Microsoft Office, Adobe Acrobat, Microsoft SharePoint, Microsoft Visio, Veeva RIM, EndNote, Transcelerate) is required
  • Strong written and verbal communication skills, including fluency in English (oral and written), are required


What We Offer:
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.