Strategic Regulatory Medical Writer
A global biopharmaceutical company is advertising a vacancy for a Senior Specialist Regulatory Medical Writer. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD), and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide. This role will last for a six month contract, with a possibility of extension.
- Leading the authoring of clinical documents.
- Writing clinical regulatory and other supporting documents/submissions for assigned studies/indications for one or more programs/molecules and managing the overall development and approval process.
- Critically analysing, synthesising, and presenting complex information from a broad range of scientific disciplines and therapeutic areas.
- Providing critical review of documents from authors assigned to document deliverables for correctness, clarity, completeness, and compliance.
- Driving consistency across projects/programs.
- Managing service providers/contractors as needed.
- Leading continuous improvement within the department and across the organisation.
- Using submissions-related expertise to improve document quality and process efficiency.
- Ensuring adherence of document to standards and processes.
- and attend meetings.
- Travelling as required.
Skills and Requirements:
- Bachelor's degree in the life sciences, preferably with an MSc or PhD.
- Experience in writing clinical regulatory documents (protocols, CSRs, IBs, etc).
- A working knowledge and understanding of the drug development process within the pharmaceutical industry.
- Significant experience in an international communications or information role.
- Regulatory writing experience such as Clinical Study Reports.
- Demonstrated regulatory writing experience gained within the pharmaceutical/medical industry/CRO.
- Willingness to undertake domestic and international travel as required by the project.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emily Oakley-Keenan at +496994189029 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.