Job Title: Senior Medical Writer, Clinical and Regulatory
Department: Medical Writing
Location: UK, Fully Remote
Job Type: 12 Month Contract /FTC
Remuneration: Up to £80,000
This is a 12-month contract role, and you MUST be able to start this role within 4 weeks.
The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided.
The SMW tracks his/her own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion.
JOB RESPONSIBILITIES:
* Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided
* Represents MW at meetings
* Drives document development meetings
* Articulates document strategy and timelines
* Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss
* Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly
* Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development
* Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict
* May review the work of junior and outsourced MWs
* May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion
* Writes in plain language style as appropriate (eg, for ICFs)
* Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience
* May mentor junior staff
* Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
* Remains compliant with internal training
JOB REQUIREMENTS:
Education
* Bachelor's degree (advanced degree preferred)
Experience
* Minimum of 3 years of relevant MW experience including working knowledge of biostatistics.
* Strong knowledge of the clinical research process and regulations/guidelines
* Clinical document reading, writing, and editing experience
* Strong organizational, interpersonal and communication skills
* Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems
* Ability to manage multiple projects
* Familiarity with ICH GCP guidelines
For more information, please reach out to lucy.kirkaldy@cpl.com
You MUST be UK based and hold the Full Right to Work