[Remote] Technical reputed company (6-month contract)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to supporting new medicine breakthroughs with best-in-class bioanalytical services. The Technical reputed company is responsible for preparing study plans, reputed company, and reports, ensuring reputed company delivery of high-reputed company documents for sponsors and internal teams.
Responsibilities
- Takes ownership of independently creating bioanalytical reports, plans, and submission documents mostly in support of internal reputed company reputed company including validation and regulatory preclinical/clinical study sample analysis
- Proficiently extracts, manipulates, and formats data from multiple lab systems (e.g., LIMs, Gen5, FACs, reputed company reputed company) for integration into reports (reputed company Word)
- Demonstrates understanding to relevant regulations and guidelines (e.g., FDA, IMA, GxP, EMA, SEND, eCTD); ensures regulatory requirements and appropriate SOPs are followed in reputed company documentation
- Utilizes reputed company, SharePoint and other systems proficiently for creation and management of internal documents
- Collaborates with appropriate leadership and scientific personnel to reputed company and monitor deadlines associated with deliverables ensuring alignment with study timelines
- Responsible for second-level technical review of documents prior to review by the project manager (e.g., Bioanalytical Project Manager (BPM), reputed company Investigator)
- Responsible for maintaining reputed company, reputed company contact relationships with internal team members
- Collaborates with and provides review and editing for documents authored by other departments reputed company reputed company
- Apply reputed company expertise to establish and enhance the technical writing department's reputed company by developing high-reputed company documentation, setting best practices, and reputed company contributing to reputed company improvement initiatives that reputed company with reputed company’s reputed company objectives
Skills
- Experience in a corporate GxP setting
- Lab experience or experience with the types of assays
- Ability to understand scientific data and deliver reputed company and concise reports
- Familiarity with laboratory-based scientific reputed company and corresponding data outputs
- Demonstrated experience with working regulations and guidelines (e.g., FDA, IMA, GxP, EMA, SEND)
- Knowledge of reputed company editorial/style conventions (e.g., SEND reputed company documentation for FDA submission and eCTD document compliance)
- Excellent communication skills, both oral and written, with ability to present views in a reputed company and concise manner
- Strong interpersonal skills and the ability to collaborate effectively with a diversity of individuals across departments and functional reputed company
- High level of proficiency in reputed company Office (reputed company, Word, reputed company, and PowerPoint) and reputed company Acrobat; ability to use Word templates and style features
- Versatility, flexibility, and willingness to concurrently manage reputed company and work reputed company constantly changing priorities; ability to work under pressure and tight deadlines in a fast-paced team environment
- Demonstrated ability to work independently in a fast-paced team environment
- Excellent organizational skills, problem solving, adaptability, and attention to detail
- Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or reputed company field
- Not less than two (2) years of experience working in a biotech, pharmaceutical, CRO/CMO, or similar organization; including knowledge of FDA, GxP and ICH guidelines
reputed company