Senior Medical Writer

Job Title: Senior Medical Writer

Location: Hybrid (4 days onsite in London Bridge)

Term: Permanent, Full-time

Salary: Competitive + Benefits (Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more)

Richmond Pharmacology is a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors. With a commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life-changing therapies.

Role Description

We are seeking a seasoned and accomplished Senior Medical Writer (SMW) to join our growing team. You will play a critical role in shaping our medical and scientific communications, ensuring clarity, accuracy and impact for diverse audiences. As a leader and mentor, you will contribute extensively to project development, execution and sponsor satisfaction. The SMW is responsible for compiling more complex study documents. The SMW liaises directly and independently with sponsors, regulatory authorities and ethics committees and can perform high level of Quality Control (QC) of all documents generated within the MW department. This role supervises less experienced colleagues in the team and is responsible for SOP and template updates.

Main duties and responsibilities

• Lead junior medical writers to deliver high quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with global/regional/local regulatory and ethical requirements.
• Write and review various clinical and regulatory documents such as, but not limited to, clinical study protocols (CSPs), clinical study reports (CSRs), informed consent forms (ICFs), summary documents, advertising material and regulatory responses.
• Complete the following regulatory submissions independently: MHRA - IRAS, FDA - IND and EMA - CTIS.
• Ensure all information is accurate, balanced, and compliant with regulatory requirements.
• Collaborate with other senior writers and sponsors to develop and execute communication plans.
• Edit and proofread your own work and the work of others to ensure high quality and adherence to style guides.
• Manage multiple projects simultaneously and meet deadlines consistently.
• Stay up-to-date on current scientific advancements and regulatory changes.
• Attend internal and external training sessions to develop your medical writing skills and knowledge.
• Assist the Head of Medical Writing to establish clinical and regulatory document timelines and strategies in accordance with internal processes.
• Attend and support the Head of Medical Writing in global sponsor meetings to discuss clinical trial set up, regulatory requirements, clinical study documents and submissions.
• Coaches or mentors more junior staff on document planning, processes, and content.
• Contribute to the continuous improvement of internal processes and best practices.
• Acquire, maintain, and apply knowledge of all relevant industry, company, and regulatory guidelines (e.g. FDA, EMA, ICH, PMDA).
• Support key departmental process improvement initiatives including training materials for a range of clinical and regulatory documents.
• Able to prepare the production of high-quality research papers, abstracts, and reports for publication in scientific journals.

Qualifications and Experience:

• At least 5 years of relevant clinical/regulatory medical writing experience is required.
• Publication(s) in peer-reviewed journals.
• Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
• Strong understanding of scientific concepts and principles.
• Excellent written and verbal communication skills with a demonstrated ability to write clearly, concisely and accurately for a variety of audiences.
• Proven ability to research and analyse complex scientific information.
• Strategic thinking with strong planning and organisational skills.
• Ability to work independently and in a multidisciplinary team environment.

Application:

If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.