Remote: Regulatory Ops – IND Support (231937)

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Description:

Our west-coast based client needs support for their Regulatory Operations team. They are a small start-up filing their first IND. They have no document management system set up, everything is currently handled by sharepoint and smartsheet, it’s all manual. They have a group writing all the sections, huge number of sections, because of the nature of their drug product there are over 200 sections being drafted. They use a word doc template to draft the sections for module 3. Their writers are inputting content, reviewers then review and approve. Need help with coordination and tracking of activities that include authoring and reviewing, communicating with stakeholders, cleaning up docs from draft to review to adjudication to approval. All done in sharepoint. Follow documents through pipeline until it’s approved. Once content is approved using templates, it goes through SMEs and technical staff, they begin entering comments and sections adding multiple tables and figures. This needs to be formatted for the publishers which is outsourced. Consultant would help with formatting of these these documents moving them along, tracking them, coordinating with stakeholders, communicating issues, cleaning up docs and ensuring formatting.

Skills:

regulatory operations, IND

Remote: Regulatory Ops – IND Support (231937)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote, United States

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