Product Labelling and Artwork PM, Business Analyst/s

Product Labelling and Artwork PM, Business Analyst/s

Project Manager – Japan-based for a global labeling optimization project and a labeling text & artwork verification tool project Plan and manage the 2 projects noted above Help update the business cases to get them approved Experience managing vendor selections and implementations a plus Agile and regulatory labeling experience preferred.  Business Analyst – Japan-based for […]

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Veeva API help

Veeva API help

Help required- someone who is very knowledgeable of Veeva APIs.  This is probably not a large project, maybe just a couple of hours, but could lead to more.  Here is the description of the business problem: we’ve been creating some forms for quick creation of Veeva objects, and that’s working fine… but I’m looking for […]

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Tox and Clinical Reports for Submission Publishing

Tox and Clinical Reports for Submission Publishing

40 PDF study reports to be prepared for submission starting Oct 12, finishing Nov 9.  Mostly tox approx 20 pages long plus attachments, some clinical.  Longest study is approx 70 pages long.  TOC to be bookmarked per guidance, hyperlinking throughout report body as necessary and to appendices and attachments.  Must be proficient with ISI/TRS Toolbox. 

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Submission Publishing, QA & QC Expert

Submission Publishing, QA & QC Expert

Expedite, manage and coordinate a multitude of interrelated activities for a submission team in the development of published submissions within the required timelines.  Perform post-publishing tasks including organization of submission printing where applicable, to ensure timely dispatch (by agency gateway; CD/DVD/paper; SharePoint upload) and archival of regulatory submissions, and effective maintenance of supporting documentation (e.g. […]

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Regulatory Strategist

Regulatory Strategist

The Regulatory Operations Leader requires seasoned help for overflow activities, specifically for regulatory strategy related items, not operations.  Marketing application filed in November, currently preparing for inspections, intensive labeling and Adprom activities.  Further tasks to be discussed.  Could be 10- 20 hours a week however to be discussed.

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Regulatory Affairs Consultant- full time 6 months (at least)

Regulatory Affairs Consultant- full time 6 months (at least)

Northeast US based drug sponsor in need of Regulatory Affairs consultant.  There is a Head of Regulatory at present but is overloaded, needs an experienced second pair of hands to jump in and start adding value in the some of the following areas- Reg strategy, labeling, FDA required updates, interacting with partners, etc. to support […]

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Manager, Technical Services

Manager, Technical Services

Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022.  Primary Responsibilities  The primary responsibilities of this role include but are not limited to: Management and oversight of all technical and building-related operations and services, including responsibility […]

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Veeva RIM Vault and Regulatory Operations Consulting

Veeva RIM Vault and Regulatory Operations Consulting

Small CA based biotech in need of an independent expert who knows both Veeva (any vault) AND regops.  “What we’re finding is that people either know one or the other.  We need both!” Number of hours and duration, not sure, it really depends on the expertise of the consultant.  Deep understanding of the regops process, […]

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eCTD Templates, Publishing and Medical Writing- 3 US INDs

eCTD Templates, Publishing and Medical Writing- 3 US INDs

Small Seattle based sponsor working to bring 3 compounds to market- oncology, Covid19 vaccine and schistosoma disease.  Content is in various stages of completion- mostly drug substance.  Need medical writing support (have synopsis but not protocol) as well as publishing in the eCTD format.  We have done INDs before but always in paper.  Have been […]

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Document Formatting Expertise

Document Formatting Expertise

Document formatting and publishing expertise needed Document formatting project.  required: Proficient in MS Word and Adobe PDF Proficient in ISI Toolbox Formatting experience Familiar with Veeva Vault (preferably Submissions Vault) Experience with report-publishing; i.e., CSRs, IMPDs, PADERs Experience with document-level publishing Up to 20 hours a week for one year with the possibility to extend.

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DMF Publishing - Quick project

DMF Publishing – Quick project

Publishing of Drug Master File, QA of links and documents.  Quick end of November project, probably 15 hours.

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Q-Sub- AI

Q-Sub- AI

Independent consulting experience needed writing/reviewing Q-Sub/Pre-Sub for a device. Product: This is an AI platform which functions as a risk assessment tool for maternal hemorrhage. Timeline: Project would commence In August 2022 and extend over the next ~45days.

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Document Formatting (and possibly templates) Expertise Needed- Large Pharma Module 4 Group

Document Formatting (and possibly templates) Expertise Needed- Large Pharma Module 4 Group

Large US hub for one of either Astellas/Takeda/Daiichi Sankyo/Chugai (need mutual NDA in place for LifeSciHub to disclose). Non Clinical Writing and Submissions group within Preclinical and Translational Sciences needs document formatting support for any and all potential content:  study reports, publications, submissions, etc. Hours and duration- to be determined.  At present the need is […]

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