Technical Writer
Durham, NC / Boston, MA
Project Management /
FT /
Remote
At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing!
The Technical Writer is responsible for the preparation of study plans, methods, study reports, and other documents. He or she ensures the timely delivery of high-quality documents for sponsors and internal team members. We are looking for candidates who have experience in a corporate GxP setting. This role is not lab-based, but our best candidates have lab experience or experience with the types of assays we do here. You are self-motivated, an independent thinker, and highly detail oriented.
As a Technical Writer your day-to-day activities will include:
- Takes ownership of independently creating bioanalytical reports, plans, and submission documents mostly in support of internal BioAgilytix projects including validation and regulatory preclinical/clinical study sample analysis.
- Proficiently extracts, manipulates, and formats data from multiple lab systems (e.g., LIMs, Gen5, FACs, Microsoft Excel) for integration into reports (Microsoft 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 all documentation.
- Utilizes ZenQMS, SharePoint and other systems proficiently for creation and management of internal documents.
- Collaborates with appropriate leadership and scientific personnel to develop 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), Principal Investigator).
- Responsible for maintaining collaborative, direct contact relationships with internal team members.
- Collaborates with and provides review and editing for documents authored by other departments within BioAgilytix.
- Apply professional expertise to establish and enhance the technical writing department's reputation by developing high-quality documentation, setting best practices, and actively contributing to continuous improvement initiatives that align with the company’s growth objectives.
These are skills needed to be successful:
- Ability to understand scientific data and deliver clear and concise reports
- Must have a familiarity with laboratory-based scientific methods and corresponding data outputs
- Demonstrated experience with working regulations and guidelines (e.g., FDA, IMA, GxP, EMA, SEND)
- Knowledge of standard editorial/style conventions (e.g., SEND ready documentation for FDA submission and eCTD document compliance)
- Excellent communication skills, both oral and written, with ability to present views in a clear and concise manner
- Strong interpersonal skills and the ability to collaborate effectively with a diversity of individuals across departments and functional groups
- High level of proficiency in Microsoft Office (Outlook, Word, Excel, and PowerPoint) and Adobe Acrobat; ability to use Word templates and style features
- Versatility, flexibility, and willingness to concurrently manage projects and work within 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.
Minimum Preferred Qualifications: Education/Experience:
- Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related 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
Working Environment:
- Primarily remote/work-from-home but may require in-office visits
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (12 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
