CMC Regulatory Affairs Technical/Quality Writing (REF11263F)

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

A Freelance Medical Writer will author regulatory, clinical trial and medical affairs documentation. Additionally, the Medical Writer will contribute to medical writing knowledge to new business proposals.

The duration of this project is for 12 months, the commitment is 40 hours per week and the job can be done fully remote from the EU/the UK.

Therapeutic area: Oncology - Solid Tumour.

Essential Functions Include:

• 5+ years experience in Regulatory Affairs Technical/Quality Writing.
• Vaccine experience (Biologics will be acceptable)/ Module 3/ Pre-Approval.
• High-quality regulatory writing including authoring clinical summaries, briefing documents and investigation plans for submissions.
• Represent Medical Writing on project teams and, as such, advise teams and clients on content and format requirements for various documents, as well as coordinate writing activities for document development.
• Ensure compliance, and remain informed on regulations and developments in medical writing.
• Maintain knowledge of product areas, current trends, and current literature.
• Providing general scientific insight for new business pitches and proposals.

• Degree in a life sciences discipline.
• Regulatory submission experience.
• Good working knowledge of the healthcare and pharmaceutical industry.
• Excellent interpersonal skills.
• Keen attention to detail.
• A positive can-do attitude.
• Ability to work independently but contribute pro-actively to a project team.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***