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- Tasks: Create high-quality regulatory documents for the pharmaceutical industry and lead writing projects.
- Company: Join Trilogy Writing & Consulting, a dynamic company focused on innovation in medical writing.
- Benefits: Enjoy competitive salary, flexible remote work options, and comprehensive benefits.
- Why this job: Make a real impact in healthcare by contributing to vital clinical documents.
- Qualifications: Experience in writing regulatory documents and strong communication skills required.
- Other info: Work in a supportive environment with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
We are seeking Senior or Principal Medical Writers to create high‑quality regulatory documents for the international pharmaceutical industry. The role involves writing, coordinating, and overseeing clinical regulatory documents and collaborating with clients and internal teams.
Responsibilities
- Prepare clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, CTD Clinical Summaries, Investigator Brochures, IMPDs/INDs, scientific publications) as lead writer.
- Ensure documents meet agreed timelines, monitor and manage project budgets, adhere to SOPs and client requirements.
- Provide document‑specific advice to clients.
- Oversee and coordinate other writers and QC specialists involved in documents under your responsibility.
- Project‑manage timelines and review cycles of your documents.
- Work in the client’s regulatory document management systems.
Required Writing Experience
- Several years of professional experience actively writing regulatory documents.
- Experience as lead writer on ≥3 (Senior level) or ≥5 (Principal level) of the following: Clinical Study Protocols, Clinical Study Reports, CTD Clinical Summaries, Investigator Brochures, IMPDs/INDs, scientific publications.
- For Principal level: experience with at least two different CTD dossier types (e.g., full new chemical entity, variation, generic, orphan, literature‑based).
- Direct client interaction, coordinating review cycles, meetings, and project timelines.
- For Principal level: willingness to take on any project requiring a Lead Writer.
- Competency using document management systems and review tools.
Additional Qualifications
- Diploma/Master’s/Bachelor’s degree in science or pharmacy (Ph.D. not required).
- Fluent written and spoken English.
- Attention to detail and appreciation for high‑quality documents.
- Excellent interpersonal skills and ability to work proactively in a diverse team.
- Flexibility and focus under tight timelines.
- Must live in the UK, Germany, Italy, Ireland, or Portugal.
Remuneration & Benefits
Competitive salary commensurate with experience, along with standard Trilogy benefits.
Application Requirements
- Eligible for full remote or hybrid remote work from our UK office in Cambridge.
- Submission of documents in English.
- Cover letter detailing how you meet the experience requirements.
- Curriculum Vitae.
Equal Employment Opportunity
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.
Data Privacy Statement
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 employer: Trilogy Writing & Consulting, An Indegene Company
Contact Detail:
Trilogy Writing & Consulting, An Indegene Company Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate/Principal Medical Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical writing field and let them know you're on the lookout for opportunities. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory documents. Be ready to discuss your experience with Clinical Study Protocols and other key documents. We want you to shine and show how your skills align with what they're looking for!
✨Tip Number 3
Don’t forget to showcase your project management skills! Talk about how you've coordinated timelines and managed budgets in past roles. This will demonstrate your ability to handle the responsibilities of a Senior or Principal Medical Writer.
✨Tip Number 4
Apply through our website for a smoother process! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Associate/Principal Medical Writer
Some tips for your application 🫡
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Make sure to highlight your relevant experience and how it aligns with the role. We want to see your passion for medical writing and how you can contribute to our team.
Tailor Your CV: Don’t just send a generic CV! Tailor it to showcase your experience with regulatory documents, especially those mentioned in the job description. We love seeing specific examples of your work that demonstrate your skills.
Showcase Your Attention to Detail: As a medical writer, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present high-quality documents right from the start!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Trilogy Writing & Consulting, An Indegene Company
✨Know Your Documents Inside Out
As a potential Senior or Principal Medical Writer, you should be well-versed in the types of regulatory documents you'll be working on. Brush up on Clinical Study Protocols, Clinical Study Reports, and other key documents. Being able to discuss your experience with these will show your expertise and confidence.
✨Showcase Your Project Management Skills
Since the role involves overseeing timelines and coordinating with other writers, be prepared to share examples of how you've successfully managed projects in the past. Highlight your ability to meet deadlines and manage budgets, as this will resonate well with the interviewers.
✨Demonstrate Your Client Interaction Experience
Direct client interaction is crucial for this role. Be ready to discuss specific instances where you've coordinated review cycles or led meetings with clients. This will illustrate your interpersonal skills and ability to work proactively in a team setting.
✨Prepare Thoughtful Questions
Interviews are a two-way street, so come armed with insightful questions about the company culture, team dynamics, and expectations for the role. This not only shows your interest but also helps you gauge if the company is the right fit for you.
