Associate Director, Medical Writing

Department: Regulatory Affairs

Location: South San Francisco, California, United States

 

Summary: 

 

The Associate Director, Medical Writing, 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. Success in this role requires you to be adept at working cross-functionally with stakeholders.

 

Key Responsibilities include:

 

  • 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
  • Core member of the Regulatory Affairs Team
  • 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 (NDAs, 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
  • 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

 

 

Preferred Qualifications include: 

 

  • Bachelor’s degree with 12+ years of pharmaceutical/biotechnology medical writing experience including development of regulatory documents for Phase I-III clinical trials. A Master’s with 10+ years of experience, or PhD with 7+ years can also be considered
  • 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 pharmaceutical company or contract research organization (CRO)
  • Experience managing medical writing vendors and/or contract medical writers
  • Excellent communication skills 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
  • Fluency in English in both written and oral communication skills
  • 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)

About Assembly Bio

Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world.  We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients.  We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:

An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B.  Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.

A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome.  We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.

Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome.  Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China. 

 

AAP/EEO Statement

 

Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.


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