Director, Medical Writing (Remote Position)
DIRECTOR, MEDICAL WRITING (Remote Position)
The 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 incumbent will be responsible for strategic and operational leadership of all Medical Writing activities and collaborate with internal cross-functional teams and stakeholders to prepare clinical study protocols, clinical study reports, and clinical regulatory documents for IND/CTA, NDA/MAA submissions. The Director, Medical Writing will support the Sr Director, Medical Writing as an individual contributor in the development, implementation, and maintenance of 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.
South San Francisco, California, USA (option to work remotely with occasional travel to South San Francisco)
Essential Duties and Responsibilities:
- Acts as a medical writing subject matter expert for all clinical and regulatory document preparation
- Collaborates with the Nonclinical, Clinical, and Regulatory Affairs team members to plan and prepare high quality documents under strict timelines; documents may include nonclinical study protocols and reports, clinical study protocols, protocol amendments, clinical study reports, scientific advice briefing documents, investigator brochures, safety updates, orphan designation requests, Module 2 clinical summaries and the Clinical Overview for INDs and marketing applications, and regulatory responses
- Ensures key messages are clear and consistent within and across documents
- Contributes strategically and scientifically at the project and/or study team level
- Works closely with functional leadership and cross-functional project teams to ensure effective document prioritization and development
- 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
- Demonstrated ability to communicate and write clearly, concisely, and effectively; strong aptitude for interpretation, compilation, 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
- Establishes corporate standards for clinical document preparation including formatting, style guide, review and approval processes, optimal use of technology.
- Manages external medical writing resources, eg, contract research organizations, document quality reviewers, and freelance medical writers as needed.
- Contributes to the development and standardization of templates and related processes, including updating, revising, and developing relevant SOPs and internal best practices
- 9-14 years medical writing experience in biotech/pharmaceutical industry with a BS or equivalent degree; advanced degree preferred, eg, PhD, PharmD, or MD
- 4+ years of experience leading teams and/or managing people (i.e. employees, contractors) desired for leadership positions
- Strong scientific written and oral communication skills. Commitment to detail, and ability to effectively prioritize while working on multiple programs and projects.
- Ability to clearly communicate and understand complex clinical and scientific concepts across therapeutic areas is essential
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Strong inspirational leader and people manager with the ability to motivate and get the best out of the Medical Writing staff while providing support and guidance.
- Ability to meet deadlines using both internal and external resources.
- Demonstrates strong problem solving and analytical abilities.
- Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents
- 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)
- Medical writing experience for international regulatory submissions is a distinct advantage
- Experience with integrated electronic document management systems
- Prior experience in managing, coaching, and mentoring direct reports is preferred
- The incumbent must have prior direct experience with managing and guiding high performance medical writing teams
- 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, eg, 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
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.