At a Glance
- Tasks: Create impactful medical documents and collaborate with experts in the field.
- Company: Innovative organisation focused on high-quality medical and regulatory solutions.
- Benefits: Remote work flexibility, professional development, and involvement in critical projects.
- Other info: Join a supportive team that values collaboration and excellence.
- Why this job: Make a real difference in clinical and regulatory initiatives while advancing your career.
- Qualifications: 5+ years in medical writing, especially in oncology, with strong communication skills.
The predicted salary is between 40000 - 50000 £ per year.
Are you a seasoned Medical Writer with a passion for contributing to impactful clinical and regulatory projects? Our client is seeking a highly skilled and motivated Senior Medical Writer to be an essential part of their dynamic team. This is a permanent, full-time role suited for professionals with over 5 years of experience who thrive in an innovative and collaborative environment.
About the Role
As a Senior Medical Writer, you will play a client-facing role, working closely with medical monitors and senior leadership to develop high-quality medical and regulatory documentation. Your expertise and collaborative nature will help shape scientific narratives across multiple projects. This position gives you the opportunity to contribute to critical regulatory submissions, support strategic discussions, and make a meaningful impact within a supportive and professional organisation.
Key Responsibilities
- Prepare a range of regulatory documents, including Investigational New Drug (IND) applications, clinical study protocols, Investigator Brochures, and Clinical Study Reports.
- Develop and update critical documents such as IND Annual Reports, Development Safety Update Reports (DSURs), and Patient Informed Consent Forms.
- Collaborate across functions to provide guidance and support in the preparation and review of training guidelines, manuals, and similar documentation.
- Offer mentoring to new medical writers by providing constructive feedback, direction, and support.
- Engage directly with clients and cross-functional experts, managing timelines, coordinating reviews, and overseeing review meetings with professionalism and confidence.
What You Need
- Bachelor’s degree is required, and an advanced degree is preferred.
- At least 5 years of experience in a CRO or pharmaceutical environment, with at least 3 years in regulatory medical writing focusing on oncology.
- Proven ability as a lead writer for multiple document types, including Clinical Study Protocols, Investigator’s Brochures, DSURs, and IND applications.
- Experience collaborating with clients or sponsors, managing timelines, organising review cycles, and coordinating review meetings.
- Familiarity with electronic Common Technical Document (eCTD) modules and fast-track application processes such as INDs and BTDRs.
- Strong understanding of industry principles related to drug safety, regulatory guidelines, clinical trials, oncology, and pharmacology.
- Exceptional organisational skills with the ability to manage multiple priorities and projects simultaneously.
- Outstanding communication and interpersonal skills, alongside advanced proficiency in MS Office software.
What’s on Offer
Our client offers the opportunity to work remotely across the UK providing you with flexibility whilst being part of a collaborative and innovative team. This role combines professional development, visibility in critical projects, and the chance to directly impact meaningful clinical and regulatory initiatives.
About Our Client
Our client is a well-respected and innovative organisation dedicated to delivering high-quality medical and regulatory solutions. Their team operates in a supportive and professional environment that values collaboration and excellence. With extensive expertise and a client-focused approach, our client is at the forefront of clinical and regulatory writing, offering team members the opportunity to advance their skills and contribute meaningfully to projects that matter.
Apply Today
If you are ready to take the next step in your career as a Senior Medical Writer and join a forward-thinking organisation, we’d love to hear from you. Apply now and become part of an inspiring team that thrives on excellence and collaboration.
Senior Medical Writer in Warrington employer: RBW Consulting
Our client is an exceptional employer, offering a flexible remote working environment across the UK that fosters collaboration and innovation. With a strong commitment to professional development and a supportive culture, employees are empowered to contribute to impactful clinical and regulatory projects while advancing their skills in a meaningful way. Join a team that values excellence and provides opportunities for growth within a well-respected organisation dedicated to high-quality medical solutions.
