Medical Writer - Home-based

Proclinical is seeking a Medical Writer - Home-based for a global pharmaceutical company. The Medical Writer reports to the Head of Clinical Science. Dependent upon the stage of clinical
development it may be possible that the Medical Writer will have direct reports.

Job Responsibilities:

• To fulfil the medical writing needs for the clinical and non-clinical departments
• Responsible for collation of data for non-clinical and clinical documents to support clinical development and compilation of CTD modules and provision of responses to non-clinical and clinical queries such as request for information (RFI)
• Contribute to collation of key documents in development and maintenance of clinical programme including Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD),
• Product Specification File (PSF), Investigator Brochure (IB), Informed Consent Forms (ICF),
• Protocol Synopsis and Protocol, Trial Master File (TMF) and Clinical Study Report (CSR)
• Collation of data into peer reviewed publications
• Responsible author of non-clinical and clinical documents Clinical Trial Application (CTA),
• Investigational Medicinal Product Dossier (IMPD), Product Specification File (PSF), Investigator
• Brochure (IB), Informed Consent Forms (ICF), Protocol Synopsis and Protocol, Trial Master File
• (TMF) and Clinical Study Report (CSR) and other supporting documents to support clinical development and/or marketed products as required
• Assume responsibility for the quality of content of assigned documents
• To liaise with other departments (including but not limited to non-clinical, Regulatory, CMC, Pharmacovigilance, Statistics, Data Management, Clinical Operations etc.) to develop, gather and synthesize input for the above-mentioned documents
• To support with the identification and contracting of Medical Writing companies/resource and coordinate, review and edit their deliverables in cooperation with the project/study teams and provide medical writing and QC review support as needed
• Continuous improvement in current company medical writing practices, define preferred medical writing standards, develop and maintain a departmental medical writing and document review policy and develop/update and maintain SOP(s) where needed
• To develop and maintain company standards and update based on regulations and company
• To develop and provide initial and ongoing training to all R & D functional team members on
• Medical Writing Standards on established standards and role of the reviewer
• To serve as an efficient and dedicated resource for the entire R&D team, producing documents for diverse audiences to allow the larger team to focus on content and subject matter expertise
• Assists in the writing of non-clinical and clinical abstracts, posters, and manuscripts for assigned studies

Skills and Requirements:

• Master's degree in a scientific discipline, advanced degree (Ph.D., PharmD) is advantageous but not essential
• Minimally 5 years' experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment with awareness of legislation governing clinical development toward product licensure
• Experience in creating, managing, authoring and editing clinical protocols and/or other types of clinical documents (e.g., Informed Consent Form, Investigator's Brochures, clinical parts of regulatory filing documents)
• Experience with authoring CSRs, ideally to include Phase 1-3 studies
• Experience in successful submission and acceptance of peer reviewed scientific publications including abstracts and posters.
• Familiar with non-clinical and clinical trial methodology, statistical principles / concepts used in clinical research, experience in interpretation of statistical analysis
• Ability to own all scientific and medical writing tasks as assigned and deliver assigned objectives on schedule
• Willingness to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables.
• Strong computer skills and general computer literacy
• Strong written, verbal, and interpersonal communication skills.
• Excellent communication skills (English language; written and verbal)
• Able to manage multiple projects and prioritize workload to ensure deliverables are completed per time and quality goals

To Apply:

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 call Tom Russell on +44 203 8246 104 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.