Senior Medical Writer

Cpl Life Sciences; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading life sciences company is seeking a Senior Medical Writer for a fully remote role on a 9-month contract. The successful candidate will craft clinical documents like CSR, protocols, and ICFs. They must have a Bachelor's degree with at least 3 years of Medical Writing experience. Strong skills in MS WORD and knowledge of clinical research regulations are vital. This position will require managing multiple projects and mentoring junior staff. A collaborative spirit is essential as you'll work closely with clinical teams.

Qualifications

• Minimum 3 years relevant Medical Writing experience including biostatistics knowledge.
• Strong knowledge of clinical research process and regulations.
• Experience in clinical document reading, writing, and editing.

Responsibilities

• Write content for clinical documents including CSRs, protocols, and narratives.
• Participate in document development meetings and articulate document strategy.
• Review work of junior and outsourced Medical Writers.

Skills

Organ organizational skills

Interpersonal skills

Communication skills

Knowledge of MS WORD

Knowledge of Adobe Acrobat

Knowledge of PowerPoint

Ability to manage multiple projects

Education

Bachelor's degree or advanced degree

Tools

Electronic document management systems

Job description

Job Title : Senior Medical Writer, Clinical and Regulatory

Department : Medical Writing

Location : UK, Fully Remote

Job Type : Initial 9 Month Contract / FTC

Remuneration : Up to £80,000

This is a 9 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 [e-mail]

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