Director, Medical Writing

JOB TITLE: Director, Medical Writing

DEPARTMENT: Regulatory Affairs

LOCATION: South San Francisco (Remote/Onsite/Hybrid)

TYPE: Full-Time

HI-Bio, Inc. is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. Our pipeline is strong and built through both in-licensing and discovery. HI-Bio's team is made up of industry experts from science and clinical drug development. We are on a path to building a leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.

This role is responsible for the planning, coordination, and oversight of all medical writing activities within the company. In this role you will lead the Medical Writing function and be responsible for the development and implementation of a standardized process for the development of clinical and regulatory documents and will be responsible for managing external resources. This position will report into the Senior Vice President, Regulatory Affairs.

KEY RESPONSIBILITIES:

• Responsible for planning, managing, and aligning medical writing activities and communication across multiple projects and development programs

• Oversee the development of critical documents, including Investigator Brochures, protocols/protocol amendments, and clinical study reports, in compliance with SOPs, ICH E3 guidelines, other applicable regulatory guidance documents, and local requirements

• Support the selection of CROs and vendors and provide project-level oversight of CROs and other vendors

• Develop the medical writing functional area, including creation of standardized policies, procedures, work instructions, timelines, document tools and templates, style guide, and best practices

• Responsible for clinical trial disclosure (CTD) and registration activities (e.g., CT.gov Registration/Results, EU CTR Results, Plain Language summaries, Redacted Clinical Documents). May be directly involved in activities related to CTD as well as providing oversight to vendor supporting these activities

• Effectively engage and communicate with functional area leads and stakeholders across development programs to support medical writing activities.

• Provides leadership in planning and contributing to key regulatory submissions to US and global health authorities (BLA's, MAAs, INDs, annual reports, DSURs).

• Ensures key messages are clear and consistent within and across documents.

• Contributes strategically and scientifically at the project and/or study team level.

• Responsible for forecasting costs for individual medical writing projects and CTD

• Generate and track medical writing project budgets against planned budget and timelines

• Partner with legal and financial functions to negotiate medical writing contracts and budgets

• Identify and anticipate issues related to budget and project milestones and lead mitigation and resolution efforts for issues identified

• Create and regularly update medical writing project timelines and ensure that medical writing timelines are in sync with the program timelines

• Act as a key contributor to the organization cross-functionally to promote organizational goals and knowledge sharing

• Lead and drive process improvement initiatives for medical writing and CTD, including development and maintenance of standard operating procedures

EDUCATION AND QUALIFICATIONS:

• Bachelor's degree (life science preferred) combined with +10 years of pharmaceutical/biotechnology medical writing experience including development of regulatory documents for Phase I-III clinical trials

• A Master's (MS) or PhD degree may be considered in place of years of relevant experience

• Subject matter expert in the regulatory medical writing process with strong attention to detail

• Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data

• Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and other clinical and regulatory documents required for IND and NDA submissions

• Demonstrated experience in a lead medical writing role managing projects of varying size and complexity, preferably within a biotech company or contract research organization (CRO)

• Experience managing medical writing vendors and/or contract medical writers

• Excellent communication skills, written and oral, to ensure that medical writing plans and processes are transparent, strict timelines are met, and risks, issues, and results are clear to all stakeholders

• Outstanding organizational skills with the ability to multi-task, prioritize, negotiate, manage competing priorities, analyze and solve problems

• Thorough knowledge of regulatory and compliance requirements for medical writing, including ICH E3 and other applicable guidelines

• Willing to embrace change and work in a changing environment

• Able to work collaboratively across cultures and geographies

• Proficient in Microsoft Word, Project, PowerPoint, Excel

• Proficient in Adobe Acrobat, and electronic document templates (e.g. eCTD templates)

HI-BIO RECRUITING:

HI-Bio, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.