At a Glance
- Tasks: Create high-quality regulatory documents for the pharmaceutical industry while collaborating with diverse teams.
- Company: Join Trilogy Writing & Consulting, a dynamic company focused on innovation and growth.
- Benefits: Enjoy competitive pay, flexible remote work options, and opportunities for professional development.
- Other info: Work in a supportive environment that values your ideas and promotes career advancement.
- Why this job: Make a real impact in clinical development and shape the future of healthcare documentation.
- Qualifications: Experience in writing regulatory documents and strong interpersonal skills are essential.
The predicted salary is between 50000 - 70000 £ per year.
Trilogy Writing & Consulting, An Indegene Company, is currently looking to hire Senior/Principal Medical Writers (f/w/d) to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy, you will be part of a team that provides a service that goes beyond just writing. Our writers are integral parts of clinical development teams supporting the writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As a growing company, there is room to develop with us… and your ideas will form our future together.
Applicants must live in one of the following countries: The UK, Germany, Italy, Ireland, or Portugal.
As a Senior/Principal Medical Writer you will:
- Prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate.
- Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company’s clients.
- Be responsible for providing document-specific advice to clients.
- Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
- Project manage the timelines and review cycles of your documents.
- Work in the client’s regulatory document management systems.
The candidate must have the following writing experience:
- Several years of professional experience actively writing regulatory documents.
- Worked as the lead writer on >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.
- For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application, a variation, a generic dossier, an orphan drug dossier, a literature-based dossier [e.g. a full-mixed application under Article 8(3) of Directive 2001/83/EC]).
- Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
- For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed.
- Competency in the use of document management systems and review tools.
In addition to having the above writing experience, applicants must have:
- Diploma/Masters/Bachelor’s degree in science/pharmacy (Ph.D. not necessary).
- Fluent written and spoken English skills.
- An appreciation for a well-written document and an eye for details.
- Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities.
- Flexibility and the ability to stay focused under tight timelines.
- Must live in the UK, Germany, Italy, Ireland, or Portugal.
Remuneration will be relative to the level of experience, with all standard Trilogy benefits.
Only candidates who meet the following requirements will be considered:
- Applicants will work fully remotely, or hybrid remotely from our UK office in Cambridge. Freelancers need not apply.
- Submission of documents in English.
- Cover letter specifying how you comply with the experience requirements listed above.
- CV
Trilogy Writing & Consulting, An Indegene Company, complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state/provincial, and local law. We passionately believe in creating a supportive environment in which everyone can grow, flourish, and do their best work.
Collection and use of personal data in the application process: It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within the scope of an application for employment with Trilogy are protected against unauthorized access and manipulation by technical and organizational measures, and are not forwarded to third parties. Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK, and Trilogy Writing & Consulting, Inc. in the USA. By submitting your data with this application you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation under jobs@trilogywriting.com. In the event of revocation, we will delete your personal data immediately.
Associate/Principal Medical Writer in Cambridge employer: Trilogy Writing and Consulting
Trilogy Writing & Consulting, an Indegene Company, is an exceptional employer that fosters a collaborative and innovative work culture, allowing Senior/Principal Medical Writers to thrive in their roles. With the flexibility of remote or hybrid working arrangements from our UK office in Cambridge, employees benefit from a supportive environment that prioritises professional growth and encourages contributions that shape the future of the company. Our commitment to high-quality regulatory documentation in the pharmaceutical industry ensures that your expertise will be valued and impactful.
Contact Details:
Trilogy Writing and Consulting Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Associate/Principal Medical Writer in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant webinars, and join online forums. You never know who might have the inside scoop on job openings or can refer you directly to hiring managers.
✨Tip Number 2
Prepare for interviews by practising common questions and showcasing your writing experience. Be ready to discuss specific projects you've led and how you managed timelines and budgets. This will help us see how you fit into our team!
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications after a week or so. A quick email expressing your continued interest can keep you on the radar and show us that you're genuinely keen on joining our team.
✨Tip Number 4
Utilise our website to apply directly! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us that you’re proactive and serious about wanting to be part of Trilogy.
We think you need these skills to ace Associate/Principal Medical Writer in Cambridge
Some tips for your application 🫡
Tailor Your Cover Letter:Make sure your cover letter speaks directly to the role of Senior/Principal Medical Writer. Highlight your relevant experience and how it aligns with what we’re looking for at Trilogy. This is your chance to show us why you’re the perfect fit!
Showcase Your Writing Skills:Since writing is at the core of this role, include samples of your previous work if possible. We want to see your style and attention to detail, so pick pieces that best represent your abilities in regulatory documentation.
Be Clear and Concise:When filling out your CV and application, keep it straightforward. Use bullet points for easy reading and make sure to highlight your key achievements and experiences that relate to the job. We appreciate clarity!
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your documents and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Trilogy Writing and Consulting
✨Know Your Documents Inside Out
As a Senior/Principal Medical Writer, you'll be preparing various clinical regulatory documents. Make sure you’re familiar with the specifics of Clinical Study Protocols, Clinical Study Reports, and other key documents. Brush up on the CTD format and any relevant SOPs to show you’re ready to hit the ground running.
✨Showcase Your Project Management Skills
You'll need to manage timelines and coordinate with other writers. Be prepared to discuss your experience in overseeing projects and how you’ve successfully managed review cycles. Bring examples of how you’ve kept projects on track and met deadlines, as this will demonstrate your ability to handle the responsibilities of the role.
✨Demonstrate Your Interpersonal Skills
This role involves interacting directly with clients and authors. Highlight your proven interpersonal skills during the interview. Share specific instances where you’ve effectively communicated complex information or facilitated discussions among diverse teams to achieve a common goal.
✨Prepare Thoughtful Questions
Interviews are a two-way street! Prepare insightful questions about Trilogy’s approach to regulatory writing and how they support their writers. This shows your genuine interest in the company and helps you assess if it’s the right fit for you. Plus, it gives you a chance to engage with the interviewers on a deeper level.
