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Role Description

We are seeking a Medical Writing Contractor to oversee the development and finalization of key clinical and regulatory documents.

• Leading and contributing to the development of clinical and regulatory documents such as Clinical Protocols, Clinical Study Reports, Investigator Brochures, DSURs, Briefing Packages, INDs and Amendments, BLA/MAA documents, and regulatory responses according to company standards, processes, and timelines.
• This job description outlines the primary duties and responsibilities of the role; however, it is not intended to be all-inclusive. The scope of responsibilities may be modified, expanded, or adjusted at the discretion of the organization to meet evolving business needs.

Qualifications

• Sc./M.S./Ph.D. or equivalent degree in a science or healthcare-related field combined with medical writing experience within the biopharmaceutical industry.
• Demonstrated ability to communicate and write clearly, concisely, and effectively.
• Aptitude for compilation, analysis, and presentation of data.
• Expert knowledge of AMA style, medical terminology, and clinical data analysis.
• Excellent interpersonal and influencing skills; ability to negotiate well and build good relationships with coworkers.
• Excellent technical skills and deep knowledge of Microsoft Word, Teams, and SharePoint.
• Expert knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards.
• Able to manage multiple projects in a fast‑paced environment with challenging deadlines and changing priorities.
• Experience authoring clinical regulatory documents.
• Ability to plan, manage, and optimize resources.
• Ability to assess workload and suggest prioritization to senior staff.

Requirements

• Pay Range: $75 - $84/hour
• The stated pay range for this position reflects the San Francisco Bay Area job market.
• Assembly Bio establishes pay ranges based on geographic work locations.
• Additional factors such as academic credentials and relevant experience will influence the actual salary offered.

Company Description

Assembly Bio (NASDAQ: ASMB) is an ambitious biopharmaceutical company with cutting-edge therapeutic clinical candidates capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world, and research and preclinical programs focused on the discovery of novel antivirals to treat devastating viral diseases, including HBV, hepatitis delta virus (HDV) and herpesviruses.

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 set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.

As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind. 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.

Information for Recruitment Agencies

Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.

Location

• South San Francisco, California (Remote)

Department

• 250 Regulatory & Quality Assurance

Employment Type

• Contractor

Compensation

• $75 - $84/hr