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Spyre Therapeutics

Related companies:

🏢 Precision for Medicine
🏢 Precision Medicine Group
🏢 Oscar Health

Jobs at this company:

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🔥 Clinical Trial Associate, Clinical Operations
Posted 2024-11-09

💸 65000 - 75000 USD per year

🔍 Biotechnology

  • B.A./B.S. in life sciences or equivalent is required.
  • A minimum of 2 years of clinical research experience, preferably in the pharmaceutical or biotech industry.
  • Working knowledge of FDA/ICH guidelines and Good Clinical Practices is necessary.
  • Experience with CTMS, EDC, and TMS software is preferred.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook is required.
  • Strong attention to detail, organizational skills, and ability to manage multiple tasks are essential.
  • Excellent communication and interpersonal skills are necessary for effective collaboration.

  • Proactively review and manage internal and/or external eTMF and prepare for audits.
  • Coordinate logistics for meetings, prepare agendas and minutes, and update Clinical Trial Governance.
  • Maintain staff and vendor lists, collaborate on Trial Master Data, and contribute to oversight plans.
  • Lead clinical biospecimen inventory tracking, assist with contracts and budget maintenance, and prepare for inspections.
Posted 2024-11-09
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🔥 Associate Director, Regulated Bioanalysis
Posted 2024-11-07

📍 US

🧭 Full-Time

💸 163000 - 193000 USD per year

🔍 Biotechnology

  • PhD in Chemistry, Biochemistry, Analytical Chemistry or related discipline.
  • 6-8+ years of pharmaceutical industry experience in regulated bioanalysis.
  • Experience with bioanalytical platforms: LC-MS/MS, ELISA, ECL, LBA, MSD, multiplex assays.
  • Experience with outsourcing bioanalytical assays and CRO oversight.
  • Knowledge of GLP, GCLP, and regulatory requirements.
  • Strong communication and leadership skills.

  • Lead and oversee bioanalytical activities for PK and immunogenicity assays at CROs.
  • Provide scientific input for design and development of analytical methods.
  • Collaborate with CROs to ensure timely delivery of milestones and maintain transparency.
  • Work with internal and external SMEs to resolve issues during assay development.
  • Effectively communicate results to stakeholders and contribute to regulatory submission packages.

Organizational skills

Posted 2024-11-07
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🔥 Senior Manager, Regulatory Operations
Posted 2024-10-25

📍 US

🧭 Full-Time

💸 170000 - 191000 USD per year

🔍 Biotechnology

  • Bachelor’s degree with 8+ years of experience in Regulatory Operations environment within the pharmaceutical industry.
  • Experience managing active applications and with ex-US regulatory submission requirements.
  • Advanced user of Microsoft suite and Smartsheets.
  • Experience with Veeva RIM systems and SharePoint is a plus.
  • Familiarity with computer system validation for FDA/EMA regulated systems and understanding of xml and SPL is a plus.

  • Oversees and manages all regulatory submissions and submission compliance.
  • Handles creation, publishing, submission, and archiving of regulatory submissions.
  • Manages external publishing staff for health authority submissions.
  • Develops and maintains regulatory standards and best practices.
  • Evaluates and proposes improvements for regulatory systems.
  • Leads regulatory project management activities, including submission planning.

LeadershipProject ManagementSharePointProject CoordinationCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationMicrosoft Excel

Posted 2024-10-25
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🔥 Associate Director, Data Management
Posted 2024-10-25

📍 US

🧭 Full-Time

💸 160000 - 190000 USD per year

🔍 Biotechnology

  • Bachelor’s degree is required.
  • 10+ years of data management experience in the pharmaceutical, biotech, or CRO industry.
  • Hands-on knowledge and experience in data management activities, CRF and EDC design, review, and validation.
  • Knowledge of SDTM and experience in transforming raw data into these standards.
  • Knowledge of GCP, ICH, and regulatory requirements.
  • Successful track record of working independently in a matrixed organization.
  • Excellent interpersonal communication and organizational skills.

  • Perform data management study activities and manage timelines during study start-up, conduct, database lock, and documentation archival.
  • Conduct oversight of data management CROs to ensure compliance with timelines and data quality standards.
  • Oversee and drive development of study-related data management deliverables.
  • Participate in the implementation and UAT of clinical systems.
  • Coordinate cross-functional data reviews and proactively address data trends and issue resolution.

LeadershipProject ManagementSQLData AnalysisMicrosoft SQL ServerProduct ManagementProject CoordinationCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-10-25
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🔥 Principal Medical Writer
Posted 2024-10-24

📍 US

🧭 Full-Time

💸 170000 - 202000 USD per year

🔍 Biotechnology

  • Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field.
  • Minimum of 6+ years of experience in pharmaceutical medical writing or related fields.
  • Proven track record managing clinical study protocols, amendments, and regulatory submission documents.
  • Strong knowledge of global pharmaceutical regulations, including FDA, EMA, and ICH requirements.
  • Excellent leadership, collaboration, communication, and interpersonal skills.
  • Proficient in word processing software and document management systems.

  • Lead development of clinical study protocols, amendments, investigator’s brochures, and supporting documents.
  • Develop timelines for clinical documents and ensure timely completion for regulatory submissions.
  • Co-author clinical study protocols and IBs with SMEs, manage review cycles, finalize documents.
  • Lead the development of clinical study reports (CSRs) and data summaries, co-authoring with SMEs.
  • Prepare written summaries for regulatory submission and respond to information requests from regulators.
  • Support content for meetings with regulators and identify risks in submission activities.

LeadershipProject ManagementData AnalysisProject CoordinationCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-10-24
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