At a Glance
- Tasks: Create clear and accurate medical documents for regulatory submissions and product development.
- Company: Join a dynamic medical affairs team in a leading pharmaceutical company.
- Benefits: Enjoy competitive salary, health insurance, flexible remote work, and professional growth opportunities.
- Other info: Collaborative culture that values scientific integrity and effective communication.
- Why this job: Make a real impact in the pharmaceutical industry while working from anywhere.
- Qualifications: Master's or Ph.D. in life sciences with 5+ years of medical writing experience.
The predicted salary is between 40500 - 49500 £ per year.
About the Role
Our client is seeking a highly skilled and experienced Senior Medical Writer to join their dynamic medical affairs team.
This role can be performed remotely, offering flexibility to talented writers.
You will be responsible for producing clear, concise, and scientifically accurate regulatory and medical documents to support product development and regulatory submissions.
This includes clinical study reports, Investigator's Brochures, regulatory submission documents, and publications.
The ideal candidate possesses exceptional writing skills, a deep understanding of pharmaceutical research and development, and the ability to manage multiple projects efficiently, ensuring timely delivery of high-quality documentation for the Gauteng province and global markets.
Key Responsibilities
- Write, edit, and review a variety of complex medical and regulatory documents, including clinical study protocols, Clinical Study Reports (CSRs), and Investigator's Brochures.
- Prepare documents for regulatory submissions, such as Common Technical Documents (CTDs) and briefing documents for health authorities.
- Ensure all documents are scientifically accurate, adhere to relevant guidelines (e. g., ICH), and meet regulatory requirements.
- Collaborate effectively with cross-functional teams, including clinical operations, regulatory affairs, statistics, and R&D.
- Manage multiple projects simultaneously, ensuring timely completion of deliverables.
- Stay abreast of industry trends, regulatory changes, and best practices in medical writing.
Requirements
- Master's or Ph. D. in a life science, pharmacy, or related discipline.
- Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
- Proven expertise in writing various types of regulatory and clinical documents.
- Thorough understanding of drug development processes and Good Clinical Practice (GCP) .
- Exceptional written and verbal communication skills, with meticulous attention to detail.
- Ability to work independently and manage projects effectively in a remote setting .
Benefits
- Competitive salary and performance-based bonus structure.
- Comprehensive health, dental, and vision insurance coverage.
- Generous paid time off and flexible remote work options.
- Opportunities for professional development and continuing education.
- A collaborative environment that values scientific integrity and impactful communication.
- #J-18808-Ljbffr
Senior Medical Writer in Southampton employer: Placements24
Our client offers an exceptional remote working environment for Tax Specialists, providing unparalleled flexibility and autonomy while ensuring a competitive salary package and performance bonuses. With a strong focus on continuous professional development, employees are encouraged to grow their expertise in South African tax law, all within a supportive culture that values strategic thinking and collaboration across departments.
