Head Of Regulatory Writing

Job Title: Head of Regulatory Writing

Company: Alchemy Medical Writing

Location: Remote (UK)

Salary: Up to £65k (DOE) + Benefits.

Our client, Alchemy Medical Writing, are looking for an experienced Head of Regulatory Writing to join their busy team! You must be a motivated, experienced regulatory medical writer who can take sole charge and work as a team.

If you are passionate about excelling in your job and enjoy working in a people-first company, then we would welcome your application to join the A-Team!

Why become an Alchemist?

Alchemy wouldn’t be what it is without our Alchemists. From the newest writer on the block, to the founder herself, Alchemy thrives on the easy-going but tight-knit mix of people we are. Our backgrounds are surprisingly diverse for a small team, with experience ranging from veterinary surgery to immunology research to the energy industry, and our strength lies in what each of us can bring to the table. We are an array of neurodiverse, intelligent, happy people and we want to keep this good thing growing. You’ll find the nitty gritty of what Alchemy offers below, but the dynamic is what counts the most in making coming to work every day a pleasure, and we hope you’ll join us with the same mindset. We can’t wait to welcome you to the A-Team!

Alchemy offers our new Alchemist the following:

• A genuinely competitive salary
• Discretionary annual bonus
• Enhanced employer contribution to pension
• Private healthcare insurance
• Employee benefits, discounts, and wellbeing support via a dedicated platform
• Full EMWA membership and annual conference attendance paid for
• Additional continuous personal and professional development opportunities
• In-person away days and fun virtual team building events throughout the year
• 1 paid day off annually to volunteer
• Paid entry to a sporting event annually (e.g. Tough Mudder, marathon, etc.)
• 33 days holiday a year with totally flexible Bank Holidays
• The friendliest mental health first-aider you’ll meet
• The opportunity to learn from an established, multifarious, and supportive team

Your responsibilities in return will be to:

• To be a key point of contact for clients
• Managing the distribution of projects among the team and overseeing delivery
• Develop project timelines and estimates
• Author, review, and independently manage the delivery of high quality clinical and safety documents, including clinical study reports, protocols, investigator brochures, CTD submission documents, and other documents for health authorities (e.g. briefing books, responses to questions, etc)
• Prepare for and lead kick off calls and comment resolution meetings
• Lead cross-functional communication to optimise feedback in order to produce high quality documents
• Coach, mentor and line-manage our fabulous writers wanting to gain more experience, and identify training needs for the team

Your progression opportunities include:

• Becoming an active part of the leadership team
• Leading and developing the growing Regulatory Writing department
• Liaising with potential clients to win great new business opportunities

In summary, what we want you to bring to the role:

• Education: a university life science degree or equivalent with an advanced degree or equivalent being particularly desirable.
• Experience: ≥5 years of Regulatory Writing experience, combined with scientific and regulatory knowledge, and expert knowledge of medical writing processes.
• Ability: Proven competence at prioritising and managing multiple demands and projects.
• Attitude: Equal measures of affability, adaptability, reliability, and ambition.