Senior Medical Writer - Regulatory Writing
AL Solutions, Portugal

Jordan Griffiths is seeking a talented and experienced Senior Medical Writer with expertise in regulatory writing to join his growing Biotech client. As a Senior Medical Writer, you will be responsible for producing high-quality documents that support the development and registration of pharmaceutical products.

Key responsibilities include:

• Writing and editing clinical study protocols, investigator's brochures, clinical study reports, and other regulatory documents
• Reviewing and interpreting clinical trial data to ensure accurate and compelling presentation
• Collaborating with cross-functional teams including regulatory affairs, clinical operations, and biostatistics
• Ensuring compliance with relevant regulations and guidelines
• Contributing to the development of templates and standard operating procedures

Requirements

Requirements:

• Bachelor's degree in life sciences or related field
• Minimum of 3 years experience in regulatory medical writing
• Strong knowledge of regulatory guidelines (ICH, FDA, EMA)
• Excellent writing and editing skills with attention to detail
• Proficiency in using relevant software and tools (MS Office, Adobe Acrobat)
• Ability to work independently and collaboratively in a fast-paced environment
• Strong organizational and time management skills

If you are a skilled medical writer with a focus on regulatory writing and seeking a challenging opportunity, we encourage you to apply.

Benefits

• Lamp;D funding for Conferences, networking and workshops
• Annual Performance-Based Bonus
• WFH and Remote working flexibility
• Access to online training services
• Stock Options

Job Rewards and Benefits