Principal Regulatory Medical Writer

Our client has been recognized by AMWA and EMWA as the best Global Medical Writing Consultancy. Having won several new projects with the market-leading Pharmaceutical Titans and Niche biotechs with NASDAQ funding, You will have an abundance of learning and Development opportunities to work on a variety of projects based on your preference.

This is an opportunity to work alongside VPs and Sr Directors who have been hand-picked and headhunted from the best pharmaceutical, CRO, and Medical Communications companies. You will receive training in all areas of Medical Writing to ensure you become the best and most well-rounded Medical Writing specialist possible. You will also be partnered with commercially minded specialists to support you in being sponsor-facing, leading projects and client meetings should this be an avenue you'd be itnerested in.

This is a remote-friendly role, allowing you to work from anywhere in Portugal.

Requirements

• 4+ years of regulatory medical writing experience in the biotech/pharma/Consultancy environment
• Extensive experience authoring regulatory documents for FDA and EMA submissions
• Expert knowledge of ICH guidelines and other regulations governing clinical trials
• Strong experience as Lead Writer on CTD's, CSR's or Clinical Protocols.
• Ability to work independently and collaborate cross-functionally in fast-paced environment
• Strong project management skills and ability to deliver high quality documents under tight timelines

Benefits

• L&D funding for Conferences, networking and workshops
• Annual Performance-Based Bonus
• WFH and Remote working flexibility
• Access to online training services