Senior Director, Medical Writing

Location
San Francisco, CA, United States
Posted
Sep 11, 2019
Ref
219
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
SENIOR DIRECTOR, MEDICAL WRITING

Position Summary:

Reporting to the VP, Clinical Development, the Senior Director, Medical Writing will direct and provide technical and operational writing support across GBT programs and manage external and/or internal medical writing staff. The Medical Writer will be responsible for working cross-functionally with internal customers and stakeholders to develop, implement and maintain a standardized document development process for clinical and regulatory documents. This includes, but is not limited to: directing, authoring, editing and providing input to clinical documents, documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. He/she may also author/edit and/or direct the development of pre-clinical documents. The Medical Writer will be responsible for managing external resources in support of the Medical Writing requirements.

Essential Duties and Responsibilities:
  • Works with the clinical and regulatory teams to prepare clinical documents (including Clinical Study Reports (CSRs), protocols, protocol amendments, Briefing Documents, Investigator Brochures (IBs), safety updates, Clinical Summaries of Safety and Efficacy, Clinical Overview) and pre-clinical study protocols and reports under strict timelines
  • Provides leadership in planning and completing key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Investigational New Drug (IND) submissions, and annual 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., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, CMC etc.) to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents
  • Demonstrated ability to communicate and write clearly, concisely, and effectively. 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 (CRO), document quality reviewers, freelance medical writers, etc.)
  • Contributes to the development and standardization of templates and related processes, including updating, revising and developing relevant SOPs and internal best practices and processes for critical document development


Qualifications:
  • Advanced degree (e.g. PhD, PharmD, MD) with 8+ years in medical writing experience in pharmaceutical industry
  • At least 8 years of experience in a medical writing role, including participation in submissions to the US FDA (NDA, BLA) and EMA (MAA)
  • Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and Regulatory documents, including IND and NDA submissions
  • 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
  • Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to 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
  • Manages, coaches and mentors' direct reports.
  • Assists in the day-to-day operational activities and other assignments as needed and specified by management
  • 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 references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with PubMed and/or other reference-gathering search tools
  • Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates
  • Familiarity with GCP, applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines) company SOPs and internal style guides, researches, authors, and edits

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.