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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Validation of Organoid Assay Methods

Validation of Organoid Assay Methods

Looking for an expert in validation of invitro methods that can assist in a technology validation roadmap for organoid high throughput screening. 

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Trial Master File Processing

Trial Master File Processing

Verify study, country, and site level TMF completeness and generate missing documents lists and queries as necessary. Perform TMF reviews on site, country, or study level Ensure accurate completion and maintenance of TMF and tracking tools with project specific information QC Drug Accountability Work in Veeva eTMF Vault 20-30 hours a week for 6 months, […]

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TransCelerate Common Technical Protocol integration into Starting Point Templates

TransCelerate Common Technical Protocol integration into Starting Point Templates

Mid sized Northeast US based drug sponsor‘s goal is to update our StartingPoint authoring templates (SP) and incorporate relevant aspects of TransCelerate’s (TCB) Common.  Tasks include conducting a Comparison of our current SP templates with TCB’s CPT, identify differences between TCB CPT from current templates; collect feedback from current users within the core team., execute updates to […]

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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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Supply/Dose administration Best Practices

Supply/Dose administration Best Practices

Trial projections indicate that too much supply is being utilized in the current dose administration methods used.  Need an expert to advice on supply best practices such that product is being utilized more efficiently.  Thinking a clinical affairs/trial design/clinical supply expert or perhaps even a clinician or nurse specialist could solve this issue for us. […]

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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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Study level Biostatistician- part time

Study level Biostatistician- part time

This role will provide leadership in all aspects of clinical trial research and product development as well as regulatory interactions.  Participation in the selection and oversight of the CRO to perform data management, programming, and biostatistics will be included in this role.  Consultant will be available to participate in all meetings as needed, whether they […]

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Sr. Strategy and Program Management

Sr. Strategy and Program Management

CNS small molecule sponsor just launched phase 3, looking at commercialization strategy, product launch, etc.  Senior Program Management role is soon to be empty.  Current thinking is that it may take a while to find the right permanent replacement, looking at experienced executive consultant for the gap period.  Must have small molecule NDA experience.  Company […]

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Sr. Clinical Project Manager

Sr. Clinical Project Manager

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  Primary responsibility includes oversight of clinical study execution, including project planning, resource management, CRA and CRO management, and ensuring all operational aspects of clinical trials […]

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Senior Director of Statistics, Statistical Programming and Data Management

Senior Director of Statistics, Statistical Programming and Data Management

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  Primary responsibility of this position includes, but is not limited to the following: • Managing the Statistics, Statistical Programming and Data Management functions • Supervising […]

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Seasoned Stats Programmer asap

Seasoned Stats Programmer asap

Needed asap:  seasoned programmer that has extensive experience with BIMO FDA guidance, programing ,and the creation of define.pdf etc. 

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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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Qualitative Researcher needed- Market Research

Qualitative Researcher needed- Market Research

We need a qualitative research who can help with analysis and reporting, Skills: qual research – self-sufficient; problem solve themselves vs. follow orders, and for qual researcher: synthesis, story telling and above all strong practical level of intelligence experience level: 5+ yrs. competency is more important estimated hours per week: if qual researcher who can […]

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Publication Reference Database Build in Endnote

Publication Reference Database Build in Endnote

Approximately 400 publications to be entered into Endnote for reuse in submissions.  Experience with Endnote is preferred- Endnote by Clarivate, not the endnote feature within Microsoft Word. Will be provided the scanned publications in Box.  Need to list each Publication title in Endnote, Endnote will construct the citation from there.  Work can be done during […]

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Patient Data Compliance and Governance needed for De-Identified Data project

Patient Data Compliance and Governance needed for De-Identified Data project

Emerging patient data technology start up in need of an independent expert on patient data privacy.  Company intends to ingest de-identified data from partner healthcare providers in the US, Germany, UK, France, Spain and Italy on an ongoing basis.  End goal is to simulate, as close as possible to true patient data without violating privacy […]

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Oncology Market Researcher Client Liaison- .50 time

Oncology Market Researcher Client Liaison- .50 time

We are looking for a consultant, approximately 50% time role, to work on our oncology market research efforts and serve as a Liaison to our client/s.  We are a pharmbio market research firm that specializes in digital market research insights.  We harvest and aggregate data from various online sources, analyze and product insights to our […]

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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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