Senior Medical Writer

Job Title: Senior Medical Writer, Clinical and Regulatory

Department
:
Medical Writing

Location
: UK, Fully Remote

Job Type
: 6 Month Contract /FTC

Remuneration
:
Up to £80,000

This is a 6-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
• 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
• 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

You MUST be UK based and hold the Full Right to Work