Medical Writer 1
At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
Prepares, or contributes to the preparation of straightforward clinical documents, method validation and study data reports, or site manuals for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices, under the guidance of senior staff. Participates in project teams and may lead specific tasks, consulting senior staff as necessary.
Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer’s requirements. Identifies project needs, tracks project timelines and implements client requests with senior review.
Participates in both internal and external project team meetings and liaises directly with the customer on medical/technical writing issues, as appropriate and with senior support as needed.
Facilitates appropriate internal review of assigned documents and takes responsibility for on-time delivery.
May perform QC review of documents or parts of documents prepared by more senior staff.
Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff.
Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing.
Complies with Company SOPs and participates in the implementation of new SOPs.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
Familiarity with the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients.
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
Competence in completing good first draft technical reports or clinical reports within a reasonable timeframe with limited guidance.
Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results.
Ability to give a simple presentation to a project team and/or customer, e.g. on medical/technical writing processes.
Ability to identify inconsistencies and deficiencies in statistical output as related to acceptance criteria according to SOPs.
Ability to work on several projects at once while balancing multiple and overlapping timelines.
Ability to assess workload and suggest prioritization to senior staff.
Demonstrated abilities in collaboration with others and independent thought.
Demonstrates confidence and maturity in most routine medical/technical writing situations.
Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g., OECD, MHLW).
Careful attention to detail and accuracy.
Must be computer literate.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
If you want to make an impact in the global research market, where we’re working to make a real difference in patient health, we ask you to apply now and join our team.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in a life science-related discipline, or communications, technical writing, or related field with at least 1.5 years of experience in a medical, clinical, preclinical, chemistry or related environment; or equivalent combination of education, training and experience.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
May require occasional travel.
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