Job Description

Are you a recent graduate with a BSc, MSc or PhD in Biological Science, or an individual with a bit of Pharmacovigilance industry experience who wants to move into Medical Writing?

GMP Recruitment are proud to be partnered with a hugely successful company that provides expert medical writing services to support all stages of a product\xe2\x80\x99s life cycle.

We are currently supporting their recruitment for a Junior Medical Writer to join their team on a full time, permanent contract, working from their office located in based in Crowthorne, Berkshire.

This position is a mix of office-based and home-based work - employees are office-based Mondays, Tuesdays and Thursdays with Wednesdays and Fridays being work from home days. Our client is based in Crowthorne meaning to be considered you MUST be in a commutable distance to the office or be willing to relocate.

As a Junior Medical Writer you will be responsible for the preparation and QC of PADER/PAERs, designated sections of PSURs, DSURs and other safety/regulatory documents with supervision from more senior team members.

Our client is an industry leader in the provision of pharmacovigilance medical writing services, so if you want to carve out a career as a Medical Writer, this is a great opportunity to join a fast growing and successful company that specialise in preparation of safety, clinical and regulatory documents.

This position would be perfect for a recent graduate with a BSc, MSc or PhD in Biological Science, or an individual with a bit of Pharmacovigilance industry experience who wants to move into Medical Writing.

Junior Medical Writer main duties:

• With supervision from more senior team members (designated mentors), you will prepare PADER/PAERs, designated sections of PSURs, DSURs and other safety/regulatory documents in accordance with the relevant SOPs and templates.
• Provide support for supervised QC of PADERs/PAERs and specified sections of PSURs, DSURs and other safety/regulatory associated documents in accordance with the relevant SOPs and QC checklists.
• Provide support for supervised QC until signed off as competent to perform QC independently.
• Ensure adherence to the agreed timelines for all assigned sections on a project.
• Keep up with industry developments and changes in regulatory guidelines, and as guided by senior team members.
• Comply with GCP and GVP principles and applicable regulations and guidelines.
• Undertake any additional specific duties as allocated by the Managing Director/Line Manager.

Junior Medical Writer desired skills and experience:

• An understanding of GCP and GVP.
• Collate clinical/scientific information.
• Write in a structured way, with appropriate mentorship.
• Able (with guidance) to support others in critically appraising a section of a document to ensure it is legible and clear.
• Able (with supervision) to support others in assessing whether a section of a document meets the requirements specified in ICH GCP E2F and GVP Module VII.
• Able (with supervision) to support others in checking that the contents of document tables accurately reflect the source data and that mathematical and scientific attributes (as stated in the title and headings or rows/columns) are accurate, including ensuring that footers are relevant and accurate, and that therefore the data are presented in a valid format. \xe2\x80\xa2
• Ensure filing of all documentation which Junior Medical Writer has created, is performed accurately and in a timely manner.

The successful Junior Medical Writer will be offered a basic salary of \xc2\xa324,000, which could be negotiable for someone with a PhD or previous industry experience, plus additional company benefits, career progression opportunities and more.

An immediate start can be available for the successful candidate.

If the above position sounds perfect for you, or you require more information, please click apply or contact GMP Recruitment directly.

GMP Recruitment are recruiting for this role on behalf of their client and are acting as an Employment Agency.

GMP Recruitment