Senior Director, Medical Writing

SENIOR DIRECTOR, MEDICAL WRITING

Position Summary:

The Senior Director, Medical Writing will direct and provide technical and operational writing support across GBT programs and will manage external and/or internal medical writing staff. The Medical Writer will be responsible for working cross-functionally with internal team members and stakeholders to develop, implement, and maintain a standardized document development process for nonclinical and clinical documents, documents required for regulatory submissions to US and other global health authorities, presentations, posters, and publications.

Location:

South San Francisco, California, USA (option to work remotely with occasional travel to South San Francisco)

Essential Duties and Responsibilities:

• Works with the Nonclinical, Clinical, and Regulatory Affairs team members to prepare documents under strict timelines; documents may include pre-clinical study protocols and reports, clinical study protocols, protocol amendments, clinical study reports, scientific advice briefing documents, investigator brochures, safety updates, clinical summaries of safety and efficacy, and clinical overview
• Provides leadership in planning and completing required documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and scheduled reports
• Ensures key messages are clear and consistent within and across documents
• Contributes strategically and scientifically at the project and/or study team level
• Provides editorial or review support (or coordinates external resources) for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals
• Collaborates with cross-functional team members, e.g., Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, Technical Operations, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents
• Demonstrated ability to communicate and write clearly, concisely, and effectively; strong aptitude for compilation, analysis, and presentation of data
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed team environment consisting of internal and external team members
• Ensures a consistent style of document presentation to maintain quality and ease of review, and adherence to company standards
• Procures and manages external medical writing resources, e.g., contract research organizations, document quality reviewers, and freelance medical writers, etc., as needed
• Contributes to the development and standardization of templates and related processes, including updating, revising and developing relevant SOPs and internal best practices

Qualifications:

• Advanced degree, e.g., PhD, PharmD or MD, with 8+ years medical writing experience in biotech/pharmaceutical industry
• Demonstrated experience in preparing protocols, study reports, investigator brochures, safety updates, and regulatory documents, including regulatory submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA)
• Demonstrated ability to incorporate pre-clinical data into clinical and regulatory documents
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure
• Ability to complete high quality documents under tight timelines
• Demonstrated internal and external stakeholder management and project management experience
• Demonstrated ability to represent and advocate for Medical Writing and influence without direct authority
• Prior experience in managing, coaching and mentoring direct reports is preferred
• Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents
• Proficiency with Microsoft Office and use of electronic document templates
• Experience analyzing and selecting references based on scientific and regulatory relevance; familiarity with PubMed and/or other reference-gathering search tools
• Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates
• Familiarity with Good Clinical Practice (GCP) and applicable regulatory requirements and guidance documents, e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.