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Assembly Biosciences, Inc. logo
Assembly Biosciences, Inc.

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 $48 - $58/hr

Medical Writing Contractor

Medical writerMedical writerOtherRemoteMid LevelTeam 51-200

Location

United States

Posted

106 days ago

Salary

$75 - $84 / hour

Seniority

Mid Level

No structured requirement data.

Job Description

Medical Writing Contractor

Assembly Biosciences, Inc.

POSITION SUMMARY Position Title: Medical Writing Contractor Reports to: Director, Medical Writing Status: Contractor Location: Remote Summary: We are seeking a Medical Writing Contractor to oversee the development and finalization of key clinical and regulatory documents. Specific responsibilities include, but are not limited to: - 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 Include: - 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. 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. About Assembly Bio 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

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United States
Job Closed
OtherRemoteTeam 201-500Since 2013H1B No Sponsor

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OtherRemoteTeam 11-50Since 2019H1B No Sponsor

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United States
$45 - $65 / hour
Job Closed
Arthrex logo

Senior Medical Writer (Remote)

Arthrex

Founded in 1981, Athrex is a privately held, global medical devices company specializing in providing products and medical education to make arthroscopic surger

Medical writer107 days ago

Requisition ID: 65196 Title: Senior Medical Writer (Remote) Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a (Senior Medical Writer who is responsible for managing specific aspects of the Arthrex Regulatory Affairs Medical Writing program with an emphasis on supporting regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. This position will play a critical role in regulatory approval efforts for international markets. This role will specialize in writing, editing, and reviewing clinical regulatory documents as well as support and execute general medical writing activities. 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Essential Duties and Responsibilities: - Perform systematic literature searches and reviews for clinical regulatory document creation. Interpret and synthesize literature information for use in clinical regulatory documents. - Compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesize the information to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling change. - Write, edit, and proofread Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, Summary of Safety and Clinical Performance (SSCP), Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs) in accordance with regulatory requirements. Maintain periodic updates, perform gap analysis, and revise existing documents as necessary. - Work in a cross-functional team to establish clinical study protocols and reports, data summaries from raw data and document strategies. Review clinical protocols to ensure collection of data is sufficient for regulatory submissions. - Work cross-functionally to ensure successful preparation of high-quality submission-ready clinical documentation. 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Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast paced environment. Machine, Tools, and/or Equipment Skills: Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company). Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Excellent written and oral communication skills required. 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United States
Job Closed