Prepares or contributes to the preparation of pharmacokinetic (PK) method validation and bioanalytical sample analysis reports for either internal Q² Solutions customers or external clients under the guidance of senior staff. May also prepare other technical documents and deliverables. Participates in project teams and may lead specific tasks, consulting senior staff as necessary.
- Acts as Lead Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparing assigned documents to a high standard, working in accordance with Q² Solutions Standard Operating Procedures (SOPs) and the customer’s requirements. Identifies project needs, tracks project timelines, and implements client requests.
- Participates in both internal and external project team meetings and liaises directly with the customer on bioanalytical reporting issues, as appropriate and with senior support as needed.
- Facilitates appropriate internal review of assigned documents and takes responsibility for on-time delivery.
- Performs peer review of final documents prepared by other team members.
- Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff.
- Keeps abreast of current data, trends, scientific writing/regulatory knowledge, developments and advances in area of drug development/scientific writing.
- Complies with company SOPs and participates in the implementation of new SOPs.
Minimum required education and experience
- Bachelor’s degree in a life science-related discipline, or in a communications, technical writing, or related field with at least 1-2 years of experience in a medical, clinical, preclinical, chemistry, or related environment; or equivalent combination of education, training, and experience.
Required knowledge, skills and abilities
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
- Proficiency in the use of MS Excel and Adobe Acrobat. Above average proficiency in MS Word, specifically in the use of bookmarks, fields, macros, and overall templates.
- Familiarity with the structural and content requirements of bioanalytical method validation and sample analysis study reports for internal and external clients preferred.
- Knowledge of regulations relevant to bioanalysis, such as Good Laboratory Practices (GLP) and those of other regulatory agencies (e.g., OECD, MHLW).
- Competence in completing high quality first draft reports within a reasonable time frame and with limited guidance.
- Ability to give a simple presentation to a project team and/or customer, e.g. on report writing processes in support of bioanalysis.
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
- Good understanding of common statistical methods and the interpretation of their results.
- Ability to identify inconsistencies and deficiencies in statistical output as related to acceptance criteria defined in SOPs.
- Careful attention to detail and accuracy.
- Ability to work on several projects at once while balancing multiple and overlapping timelines.
- Ability to assess workload and suggest prioritization to senior staff.
- Demonstrates ability to collaborate with others as well as to work independently.
- Demonstrates confidence and good judgement in a professional setting.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.