We are looking to welcome a motivated, experienced regulatory medical writer who can take sole charge and work as a team. Applicants should be UK-based and life-science graduates, ideally with a PhD or other research experience, although this isn’t mandatory. You’ll need at least 3 years' experience as a regulatory writer within the pharmaceutical industry or a medical writing agency under your belt to thrive in this role. We are especially keen to hear from writers with regulatory submissions experience, including authoring CTD modules.
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 and the energy industry, and our strength lies in what each of us brings to the table. We are an array of neurodiverse, intelligent, happy people, and we want to keep this good thing going. 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 (£40,000 to £72,000, depending on experience)
* 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 the opportunity to attend professional development courses
* Additional continuous personal and professional development opportunities
* In-person away days and fun virtual team building events throughout the year
* Paid entry to a sporting event annually (e.g. Tough Mudder, marathon, etc.)
* 33 days holiday a year with total flexibility around bank holidays
* The friendliest mental health first-aider you’ll ever meet
* The opportunity to learn from an established, multifarious, and supportive team
Your responsibilities in return will be to:
* Author, review, and independently manage the delivery of high-quality regulatory documents, including clinical study reports, protocols, investigator’s brochures, CTD modules, and other documents for health authorities, such as briefing books and responses to questions
* Prepare for and lead kick-off calls and comment resolution meetings
* Develop project timelines and estimates (supported by our client services team)
* Lead cross-functional communication to optimise feedback and produce high-quality documents
* Potential opportunities to coach, mentor, and line manage more junior writers
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: ≥3 years of regulatory writing experience, combined with scientific and regulatory knowledge, and expert knowledge of medical writing processes. CTD authoring experience is highly desirable for this role
* Ability: Proven competence at prioritising and managing multiple demands and projects
* Attitude: Equal measures of affability, adaptability, reliability, and ambition