Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization's clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
Prepares, or contributes to the preparation of straightforward clinical documents, method validation and study data reports, or site manuals for either internal Q2 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 Q2 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 method validation and sample study reports 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 reports within a reasonable time frame with limited guidance.
- Good understanding of common inferential and descriptive statistical methods and the 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.
- Intermediate level of proficiency in the use of MS Excel and Adobe Acrobat. Above average proficiency in MS Word, specifically in the use of bookmarks, fields, and overall templates.
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
EEO Minorities/Females/Protected Veterans/Disabled
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
Job ID: R1089710