Scientific Analyst

Insight Global; Pennsylvania; Remote; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a skilled Scientific Process Analyst to support their Dossier Development & Operations team. This fully remote role focuses on preparing essential documentation for scientific business processes, ensuring clarity and compliance across R&D teams. The ideal candidate will have a strong background in technical writing and a collaborative spirit to engage with stakeholders effectively. Join a dynamic environment where your expertise in scientific analysis and documentation will contribute to innovative solutions in pharmaceutical manufacturing. If you're ready to make a significant impact, this opportunity awaits you.

Benefits

Medical Insurance

Vision Insurance

401(k)

Qualifications

• 5+ years in technical writing and scientific documentation.
• Experience in stakeholder communications and process analysis.

Responsibilities

• Conduct gap analysis for Module 3 and review project documentation.
• Draft business processes and stakeholder communications.

Skills

Technical Writing

Scientific Business Process Analysis

Stakeholder Communications

Data Engineering Documentation

User Stories

Tools

SQL

Job description

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Base pay range

$43.00/hr - $48.00/hr

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REQUIRED SKILLS AND EXPERIENCE:

• 5+ years of experience in technical writing / scientific business process analysis and documentation
• Understanding of Large Molecule dossier content and overall outline of dossier
• Experience in technical writing, writing user stories, best practices, and stakeholder communications
• Basic understanding of data engineering activities and documentation in Module 3 to support gap analysis for Module 3 data table preparation
• Experience working in a team environment to gather stakeholder input & user requirements and to connect multiple stakeholders for resolution

NICE TO HAVE SKILLS AND EXPERIENCE:

• Knowledge of monoclonal antibody (MAb) environment and understanding of manufacturing process flow
• Experience in Structured Content Authoring (eReporting)
• Experience with SQL database queries

JOB DESCRIPTION

Our large pharmaceutical client seeks a fully remote scientific Process Analyst to join their Structured Dossier Content Authoring project team. This role supports the Dossier Development & Operations (DDO) sub-team and involves preparing documentation for Business Processes across scientific teams in R&D Therapeutics Development & Supply. The goal is to develop scalable, automated solutions for generating Module 3 (CMC) tables authored by the R&D organization. Responsibilities include:

• Conducting gap analysis for Module 3, reviewing project documentation, and input from functional leads
• Drafting new business processes for SDCA table creation and use, and documenting changes
• Collaborating on training materials and data cleanliness guidelines
• Drafting stakeholder communications about process changes following standard Change Management frameworks

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Analyst and Science

Industries

• Pharmaceutical Manufacturing

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Inferred benefits

Medical insurance, Vision insurance, 401(k)

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