Medical Writer Remote

Job Description

PE Global is currently recruiting for a Medical Writer for a leading multi-national pharmaceutical client based in London. The client is offering the option to work remotely.This contract can be either 6 months or 12 months (depending on candidates preference) and there is the possibility of future extension for the right candidate. This role with provide intermediate to advanced documentation preparation and document projectmanagement skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.Role:

• Drafts and edits documents used for submissions including CTDs and RtQs
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigators brochures and periodic safety reports (PSURs, DSURs, etc.)
• Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Works effectively with cross-functional groups within the company
• Other tasks as assigned.

Requirements:

• Bachelors or higher degree preferred; scientific focus desirable.
• Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Confidential Page 2
• Evidence of medical writing career development desirable, e.g., American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
• Medical writer in the pharmaceutical industry or Medical or scientific writing experience as a primary job responsibility
• Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
• Familiar with clinical study data collection and results reporting.
• Previous protocol development experience required.
• Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
• Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
• Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
• Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
• Ability to interpret basic tabular and graphical clinical data presentations.
• Ability to create basic tables using AMA style (e.g., Schedule of Events).
• Intermediate applied knowledge of basic clinical laboratory tests.
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• Basic understanding of biostatistical and clinical research concepts.
• Basic knowledge of regulatory requirements and guidance associated with standalone regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).

Interested candidates should submit an updated CV.Please click the link below to apply, or alternatively send an up to date CV to***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, weare making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you justwant to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in thisadvert.