CROMSOURCE

Medical Writing Specialist, United Kingdom - L

Company
CROMSOURCE
Location
United Kingdom
Salary
Competitive
Posted
04 Feb 2021
Closes
06 Mar 2021
Ref
HQ00002446
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Medical Writing Specialist to join our client-based team. This is for one of the leading global biopharmaceutical companies, with a focus on Neurology and Immunology.

Scope of the role:

Global Medical Writing (GMW) contributes to the global clinical development of innovative medicines for the treatment of patients with severe diseases by delivering high-quality, scientifically-sound, and timely submission-related documents. This role performs quality control (QC) checks of clinical submission documents, thereby contributing to the successful development, registration in key regions, and commercialization of new drugs and biologic agents.

Clinical submissions documents in scope include: Phase 1-4 protocols and clinical study reports (CSRs), summary documents, risk management plans (as needed), patient narratives, and clinical parts of Investigational Brochures, agency meeting briefing packages, INDs, and responses to agency questions, lay summaries, and redacted documents; and other documents that may be assigned.

Job specific tasks and responsibilities:
  • Provide QC support to writing functions to ensure timely, high-quality deliverables in compliance with Standard Operating Procedures (SOPs), FDA, EMEA, ICH, and national and local regulations, as applicable
  • Manage and perform QC of clinical submissions documents which includes data verification, verification of document completeness and consistency within a document and between related documents, spelling and grammar checks (as needed), reference checks, and verification that a document is consistent with company and project-specific writing conventions and styles
  • Provide expertise on process, content, checklists, efficiencies, timelines, and interdependencies
  • Coordinate with other Medical Writing Specialists as needed to maintain consistency across documents within a project and across indications. Identify trends in quality deficiencies and recommend corrective actions
  • Use functions of Electronic Document Management Systems (EDMS) and PleaseReview for quality review, electronic formatting, compiling and finalizing of medical writing deliverables
  • Maintain and demonstrate expert knowledge of company- and project-specific guidelines for the QC of clinical submissions documents, including SOPs, templates, and document writing conventions and styles


Education and Experience:
  • Bachelor's degree
  • A professional certification (eg, AMWA, EMWA, RAPS, BELS) is a plus, but not essential
  • Five or more years' experience performing quality checks to medical writing functions


Skills:
  • Demonstrated ability to work without close supervision
  • Ability to work within an international team setting
  • Ability to work under pressure
  • Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines
  • Must be detail-oriented, thorough, and methodical
  • Exceptional written and verbal communication skills
  • Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
  • Exceptional problem-solving capabilities and organizational skills
  • Exceptional proofreading skills
  • Ability to focus on the details in a document without losing sight of the document messaging
  • Intermediate knowledge of medical, pharmaceutical, and clinical research concepts, including a comprehensive understanding of the clinical trial procedures and drug development process
  • A high degree of familiarity with statistical and data output.
  • Intermediate understanding of applicable regulations and guidelines (eg, Code of Federal Regulations, European Directive, and ICH) including CTD structure and content, CSR and summary document content
  • Strong computer skills; proficiency in MS Office Suite, and EDMS
  • Can manage uncertainty and shifting priorities and timelines
  • Able to collaborate productively with colleagues and supervisors
  • Able to adapt to working in a multicultural environment; able to adapt to change
  • Able to think independently and apply principles across various situations and appropriately apply judgment to making changes
  • Able to adopt an entrepreneurial and innovative style when necessary


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002446

or please contact Rocio.EgeaMota@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Medical Writing Specialist
Skills: Medical Writing Location: United Kingdom Share:

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