Senior Regulatory Medical Writer and Student Success Lead
Senior Regulatory Medical Writer and Student Success Lead

Senior Regulatory Medical Writer and Student Success Lead

Full-Time 45000 - 55000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Deliver training on regulatory writing and mentor aspiring professionals in the pharmaceutical industry.
  • Company: PharmaLink Academy, a leader in healthcare training and mentorship.
  • Benefits: Flexible remote part-time role with impactful teaching opportunities.
  • Why this job: Shape the future of regulatory writers while sharing your expertise.
  • Qualifications: 10+ years in regulatory medical writing and strong mentoring skills.
  • Other info: Engage with students and alumni to enhance their career success.

The predicted salary is between 45000 - 55000 £ per year.

PharmaLink Academy is a specialised training academy focused on helping healthcare and life sciences professionals transition into careers within the pharmaceutical industry. Through structured, instructor-led programs, practical assignments, and expert mentorship, the academy equips students with the real-world knowledge and regulatory understanding needed to succeed in areas such as Regulatory Medical Writing and Pharmacovigilance.

We are now creating a permanent part-time position for a Senior Regulatory Medical Writer who will combine their industry expertise with training, mentoring, and student success leadership. This role is ideal for experienced regulatory professionals who enjoy teaching, guiding early-career professionals, and shaping the next generation of regulatory writers.

Important Note: This role is designed for professionals with hands-on regulatory medical writing experience within pharmaceutical companies, CROs, or regulatory consulting environments. We are specifically seeking professionals experienced with regulatory documentation used in pharmaceutical submissions.

Role Overview: This position combines regulatory medical writing expertise with training and mentorship. You will deliver structured live sessions explaining regulatory frameworks and documentation, review student assignments, and provide career guidance to professionals transitioning into regulatory writing. The role is remote and part-time, designed for experienced regulatory writers who want to share their expertise while maintaining flexibility.

Key Responsibilities:

  • Deliver Regulatory Writing Training
  • Conduct live training sessions on regulatory medical writing and pharmaceutical documentation
  • Teach key frameworks including ICH guidelines, CTD/eCTD structure, Clinical Study Reports, and protocols
  • Break down complex regulatory documentation in a clear and structured way for students
  • Assignment Review & Feedback
  • Review student assignments related to regulatory writing
  • Provide detailed, structured feedback to improve writing clarity and regulatory alignment
  • Evaluate assignments based on regulatory documentation standards
  • Student Mentorship & Career Support
  • Guide students with CV preparation, interview readiness, and job search strategy
  • Help students understand career pathways in regulatory medical writing
  • Provide professional guidance and encouragement during the transition into industry roles
  • Alumni Engagement & Placement Support
  • Maintain relationships with graduates after course completion
  • Support students during their early regulatory careers
  • Contribute to improving student placement success

Typical Regulatory Documents You Should Have Experience With: Ideal candidates will have hands-on experience writing or contributing to documents such as:

  • Clinical Study Reports (CSR)
  • Clinical Protocols
  • Investigator Brochures
  • Clinical Summaries or Overviews
  • CTD / eCTD submission modules
  • Regulatory submission documentation

Ideal Candidate Profile: We are seeking experienced regulatory professionals who combine technical regulatory expertise with strong communication and mentoring ability.

Requirements:

  • Minimum Life Sciences degree (Pharmacy, Biotechnology, Life Sciences, or related field)
  • 10+ years of experience in Regulatory Medical Writing
  • Experience working in pharmaceutical companies, CROs, or regulatory consulting environments
  • Strong understanding of ICH guidelines and regulatory submission frameworks
  • Experience with CTD/eCTD structure and regulatory documentation
  • Comfortable delivering live teaching or training sessions
  • Strong written communication and feedback skills
  • Interest in mentoring professionals entering the pharmaceutical industry

Ideal candidates may currently work as:

  • Regulatory Medical Writer
  • Senior Medical Writer
  • Regulatory Affairs Writer
  • Clinical Regulatory Documentation Specialist
  • Principal Medical Writer

Working Hours: 20–25 hours per week. Live sessions delivered at 6:00 p.m. BST. Candidates must be comfortable presenting at this time.

Why Join PharmaLink Academy:

  • Work with professionals transitioning into the pharmaceutical industry
  • Share your regulatory expertise and shape future regulatory writers
  • Flexible remote part-time structure
  • Opportunity to create long-term impact through training and mentorship

How to Apply: Interested candidates should send CV and portfolio to voke@pharmalinkacademy.co.uk highlighting:

  • Regulatory medical writing experience
  • Pharmaceutical or CRO background
  • Experience with regulatory documentation and submissions

Senior Regulatory Medical Writer and Student Success Lead employer: PharmaLink Academy

PharmaLink Academy is an exceptional employer that offers a unique opportunity for experienced regulatory professionals to share their expertise while enjoying the flexibility of a remote part-time role. With a strong focus on mentorship and student success, employees can make a meaningful impact by guiding the next generation of regulatory writers in a supportive and collaborative work culture. The academy prioritises professional growth, providing avenues for alumni engagement and career support, making it an ideal workplace for those passionate about shaping the future of the pharmaceutical industry.
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Contact Detail:

PharmaLink Academy Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior Regulatory Medical Writer and Student Success Lead

✨Tip Number 1

Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the lookout for opportunities. Attend industry events or webinars to meet potential employers and fellow professionals who can help you land that dream job.

✨Tip Number 2

Show off your expertise! When you get the chance to chat with hiring managers or during interviews, make sure to highlight your hands-on experience with regulatory documents. Share specific examples of your work to demonstrate your knowledge and skills in regulatory medical writing.

✨Tip Number 3

Practice makes perfect! Prepare for interviews by doing mock sessions with friends or mentors. Focus on common questions related to regulatory writing and be ready to discuss your approach to teaching and mentoring, as this role involves guiding early-career professionals.

✨Tip Number 4

Don't forget to apply through our website! We love seeing applications from passionate candidates who want to make a difference in the pharmaceutical industry. Make sure your CV and portfolio showcase your regulatory writing experience and your enthusiasm for mentoring others.

We think you need these skills to ace Senior Regulatory Medical Writer and Student Success Lead

Regulatory Medical Writing
Pharmaceutical Documentation
ICH Guidelines
CTD/eCTD Structure
Clinical Study Reports (CSR)
Clinical Protocols
Investigator Brochures
Written Communication Skills
Mentoring and Coaching
Training Delivery
Feedback and Evaluation
Career Guidance
Life Sciences Knowledge
Regulatory Submission Standards

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights your regulatory medical writing experience and any relevant roles in pharmaceutical companies or CROs. We want to see how your background aligns with the position, so don’t hold back on showcasing your expertise!

Showcase Your Teaching Skills: Since this role involves mentoring and training, include any teaching or mentoring experiences you've had. We’re keen to know how you can break down complex topics and guide early-career professionals through their journey.

Be Clear and Concise: When writing your application, clarity is key! Use straightforward language to explain your experience with regulatory documentation and frameworks. We appreciate a well-structured application that reflects your writing skills.

Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates from us!

How to prepare for a job interview at PharmaLink Academy

✨Know Your Regulatory Stuff

Make sure you brush up on your knowledge of ICH guidelines, CTD/eCTD structures, and the types of regulatory documents you'll be discussing. Being able to speak confidently about Clinical Study Reports and Investigator Brochures will show that you're not just experienced but also passionate about the field.

✨Prepare for Teaching Scenarios

Since this role involves delivering training sessions, think about how you would explain complex regulatory concepts to someone new to the field. Practise breaking down these ideas into simple terms, as this will demonstrate your ability to mentor and guide students effectively.

✨Showcase Your Feedback Skills

Be ready to discuss how you provide constructive feedback on student assignments. Think of examples where your feedback has helped others improve their writing clarity and regulatory alignment. This will highlight your mentoring capabilities and your commitment to student success.

✨Engage with Career Guidance

Prepare to talk about how you can assist students with CV preparation and interview readiness. Share any strategies you've used in the past to help others transition into regulatory roles, as this will showcase your understanding of the career pathways in regulatory medical writing.

Senior Regulatory Medical Writer and Student Success Lead
PharmaLink Academy

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