Regulatory Writer (m/f/n) – parenteral nutrition – Freelance

Details

Description

Goal:
In this a regulatory/medical writing project, up to 30 study publications (currently 27) in the field of parenteral nutrition (PN) are to be summarized to yield standalone CTD material of the respective publication, which will be integrated into Modules 2.7.3 2.7.4, and 2.7.6 by the sponsor. The publications (see reference list below) focus on clinical trials in pediatric patients receiving intravenous lipid emulsions. This includes that efficacy and safety data reported in the publications are to be extracted.

Services:
1. Writing study summaries of 30 published studies (provided as PDFs in English language) from the literature in separate Word documents within a predefined time frame
− 100% quality control of data/numbers/tables against source (=PDF of original publication)
− One initial preview of first summaries.
− One review round of all summaries at the sponsor and incorporation by the provider
2. Sorting efficacy and safety data from the above mentioned 30 published studies (point 1.) in the corresponding efficacy Module 2.7.3 and safety Module 2.7.4 sections of a provided CTD template. In each module, each publication needs to be presented as subsection under its own heading titled by First Author name, Year.
− 100% quality control of data/numbers/figures against source (=original publication)
− One initial preview of first efficacy and safety section, respectively. One review round of all summaries at the sponsor and incorporation by the provider
3. A) Tabular provision of basic study data according to provided CTD module 2.7.6 (includes example data).
B) Provision of synopses for each of the 30 studies, as based on summaries M 2.7, in format as in sample provided by sponsor
− 100% quality control of data/numbers/figures against source (=original publication)
− One initial preview of first synopses.
One review round of all synopses at the sponsor and incorporation by the provider
Delivery as MS Word documents (copyable content, no macros by the provider). Templates of Modules 2.7.3 and 2.7.4 by the sponsor are to be used and the sponsor’s writing standards to be followed. PDFs of literature PDFs are planned to be provided to provider by sponsor, under copyright clearance.

Delivery:
1. 30 separate WORD (.docx) documents based on provided templates (named by first author_year)
2. 2 separate WORD (.docx) documents based on provided files for CTD module 2.7.3 and 2.7.4, respectively.
3. 1 WORD (.docx) document based on provided CTD module 2.7.6

Requirements:
Analytical reading and writing skills to completely identify, extract, and summarize content such as (but not limited to) the study design, PN treatment, primary and secondary efficacy and safety results, outcomes in an overview style as necessary for M2.7.3, 2.7.4 (summaries), and 2.7.6 (table and synopses).

Additional information:
Start Date: Asap
End Date: 13.01.2025
Location: Remote

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