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 [email protected]

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