CMC Report Writer

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POST DATE 9/2/2016
END DATE 10/12/2016

Bulletproof Documentation, Inc. Redwood City, CA

Company
Bulletproof Documentation, Inc.
Job Classification
Full Time
Company Ref #
360590
AJE Ref #
576067006
Location
Redwood City, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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html body p span style="font-size: 12pt;" strong Scope of Work: /strong /span /p p span style="font-size: 12pt;" In support of preparation of the CMC sections of the BLA for biosimilar products, CMC report writer responsible to develop body of required CMC technical reports. /span /p p span style="font-size: 12pt;" Provide approved reports to client and/or their CRO.  Focus on biologics process development and validation, span style="font-family: arial, helvetica, sans-serif;" including /span cell culture, purification and fill/finish.  Additional support in other CMC areas also may be required. /span /p p span style="font-size: 12pt;" strong Responsibilities: /strong /span /p ul li span style="font-size: 12pt;" Work with client to access source materials: /span ul li span style="font-size: 12pt;" Approved protocols /span /li li span style="font-size: 12pt;" Executed protocols and worksheets /span /li li span style="font-size: 12pt;" Data reports and raw data /span /li li span style="font-size: 12pt;" Subject matter expert and stakeholder input and knowledge /span /li li span style="font-size: 12pt;" Document templates and tools /span /li /ul /li li span style="font-size: 12pt;" Leveraging source materials to develop technical reports. Reports may be written from-scratch or through adaptation as appropriate. Reports to be: /span ul li span style="font-size: 12pt;" In alignment with client reports formats/templates /span /li li span style="font-size: 12pt;" In full agreement with source materials /span /li li span style="font-size: 12pt;" Accurate and true to the data /span /li li span style="font-size: 12pt;" Aligned with the protocol/program requirements and acceptance criteria /span /li li span style="font-size: 12pt;" Defendable to an auditor and regulatory agency /span /li /ul /li li span style="font-size: 12pt;" Utilize existing client processes and tools throughout execution. /span /li li span style="font-size: 12pt;" Proofread all reports for: /span ul li span style="font-size: 12pt;" Language and grammar /span /li li span style="font-size: 12pt;" Correction of ambiguous or confusing wording /span /li li span style="font-size: 12pt;" Ensure integrity of content; to not change meaning /span /li /ul /li /ul ul li span style="font-size: 12pt;" Do the “heavy-lifting”; minimize client resources wherever possible. /span /li li span style="font-size: 12pt;" Follow-up with reviewers and stakeholders to ensure reports meet project timelines. /span /li li span style="font-size: 12pt;" Apply cGMP/CMC knowledge and expertise when developing the reports. /span /li li span style="font-size: 12pt;" Partner with client team members to identify issues, formulate recommendations, and execute solutions, as applicable. /span /li li span style="font-size: 12pt;" Lead and facilitate report review meetings. Focus on reconciling feedback and adjourning with approvable reports. /span /li li span style="font-size: 12pt;" Manage report approval process. /span /li li span style="font-size: 12pt;" For specific projects, develop and manage a report tracker that: /span ul li span style="font-size: 12pt;" Contains a complete list of all reports in scope /span /li li span style="font-size: 12pt;" Lists due dates for each step of the development and approval process /span /li li span style="font-size: 12pt;" Aligns with the client project milestones /span /li li span style="font-size: 12pt;" Captures status of each report; includes those that are late, with whom, and why /span /li /ul /li /ul ul li span style="font-size: 12pt;" Send routine progress reports to the client project lead, including updated report tracker, summary of notable events, areas of concern, and look ahead. /span /li li span style="font-size: 12pt;" Provide a list of parking lot and open items (if any) at time of handoff. /span /li li span style="font-size: 12pt;" Work closely with other CMC report writer(s) to ensure consistency and cohesion across the body of reports in voice, tone, format, and style. /span /li li span style="font-size: 12pt;" Accommodate teleconferences with individuals in other geographies as required. /span /li li span style="font-size: 12pt;" Be available for domestic travel as required. /span /li li span style="font-size: 12pt;" Work to be performed at client site. /span /li li span style="font-size: 12pt;" Assist with related CMC documentation and BLA preparation activities, as requested. /span /li /ul