Are you an experienced Quality Document Manager? Or, do you have a background in Medical Writing? If so, our Biotechnology client is looking for individuals just like you!
The successful candidate will perform quality review to ensure documents authored by the Safety Surveillance and Aggregate Reports team or their vendors are of high quality and support process improvement.
This is a contract position offered initially on a 12 month contract basis working 37.5 hours a week Mon-Fri.
Responsibilities:
- Perform QC Review of documents.
- Verify data in assigned documents against source documentation, including checking text against database outputs.
- Perform editorial and technical review for grammatical and stylistic consistency in line with the Style Guide and document templates. This includes reviewing format, internal linking, and external cross-referencing.
- Document QC findings so that appropriate actions can be taken by authors. Where needed, meet with the author to discuss findings and strategize the next steps (in case the error lies within the source document), including support with the development of preferred text.
- Document QC metrics for quality tracking.
- Review vendor authoring and QC as part of oversight activities.
- Support the creation of training material for new staff members and vendors on quality requirements.
- Support the preparation of aggregate report quality trends for discussion at regular team meetings.
- Assist with the development and maintenance of training materials and Job Aids.
- Assist with maintenance of SSA templates.
- Assist with SSA process improvement initiatives for quality documentation and technical tools/systems, including developing new templates.
- Represent the department, where appropriate, in cross-functional improvement initiatives.
- Perform general administrative tasks such as maintaining spreadsheets and communicating summaries and results with the relevant stakeholders.
- Provide support to other functions within SSA, which may include activities outside of QC review (e.g., vendor management, aggregate report processes, SharePoint maintenance, literature activities).
Experience and skills:
- Bachelor's Degree in biologic, natural science, or health care discipline.
- Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
- Previous writing and editing experience, preferably in the pharmaceutical or biotech industry.
- Comfortable with medical concepts and terminology; familiar with the American Medical Association (AMA) Manual of Style.
- Familiar with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and postmarketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
- Ability to understand, interpret, analyse, and clearly present scientific and medical data in verbal and written format.
- Ability to interact collaboratively and effectively in a team environment.
- Strong organisational skills, including the ability to prioritise independently.
- Proficient and comfortable using Microsoft Office (in particular, Word, Excel, and PowerPoint) and SharePoint platforms.
- Familiar with Documentum-based systems.
- Knowledge of common safety database systems.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
