Project Engineer

Planet Pharma Staffing Limited; Chester; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global CRO is seeking a Senior Medical Writer on a 12-month contract in Chester. The role entails preparing important clinical and regulatory documents, leading writing discussions, and ensuring compliance with SOPs. Ideal candidates will exhibit strong communication skills, leadership experience, and the ability to navigate project management effectively.

Qualifications

• Experience as a lead writer on submission documents is essential.
• Must demonstrate strong communications and leadership skills.

Responsibilities

• Author critical documents, including protocols and regulatory submissions.
• Lead clinical writing discussions, ensuring stakeholder engagement.
• Manage multiple assignments efficiently.

Skills

Strong communication

Project management

Ability to work independently

Job description

Planet Pharma are working with a global CRO, who are seeking a Senior Medical writer to join them on 12 month contract. As a Senior Medical Writer, you will be responsible for preparing critical clinical and regulatory documents, including protocols, investigator brochures, informed consent forms, clinical evaluation reports, and regulatory submissions. Your expertise will play a vital role in ensuring timely, clear, and accurate communication across teams and stakeholders.

Key Responsibilities:

• Author critical documents, including protocols, IBs, ICFs, CERs, PIPs, and regulatory submissions.
• Lead clinical writing discussions, ensuring strategy alignment and stakeholder engagement.
• Interpret and summarize clinical data for regulatory approval.
• Provide guidance and training to other writers.
• Manage multiple assignments, prioritizing efficiently.
• Ensure compliance with Fortrea and client SOPs.

Required Skills:

• Strong communication and leadership in cross-functional teams.
• Project management expertise, driving tasks to completion.
• Ability to work independently, solving challenges proactively.
• Experience as a lead writer on submission documents.