Genomics Technical Writer

Jobinhalt

Be part of our mission to disrupt the healthcare and democratize the data driven medicine! SOPHiA is looking for a Genomics Technical Writer to join our Genomic Research team in Europe or Switzerland.

The Genomics Technical Writer is responsible for preparing documentation including product development plans, experimental protocols, results summaries and performance evaluation plans/reports. These will contribute to design history files and regulatory submissions for next generation sequencing (NGS) products. The Genomics Technical Writer will actively engage with cross-functional R&D teams to achieve a solid scientific understanding of the products being developed and ensure a high standard of technical documentation. They may also contribute to documents such as scientific publications and customer communications.

The role is home office based in EU or CH and reports into the Director Genomic Research.

Key Responsibilities:

• Prepare product development documentation including development plans, reports and other technical documents

• Proofread and ensure documents meet internal and external Quality and Regulatory policies and guidelines
• Engage with cross-functional R&D teams throughout the product development cycle
• Facilitate and track document routing and approval
• Standardize and streamline documentation processes
• Aid in the preparation of technical documents for regulatory submissions

Requirements:

• Higher degree in life sciences
• One, preferably two years hands-on experience conducting Next Generation Sequencing (NGS) experiments, analysing NGS data or developing bioinformatics software

• Excellent scientific/technical writing ability (industry experience preferred)
• Ability to interpret and summarize complex data
• Detail oriented with excellent proofreading and editing skills
• Extremely organized and reliably respect deadlines
• Proficient in written English

Candidates with one or more of the following additional skills are preferred:

• Familiarity with development and regulatory processes for in vitro diagnostic medical devices
• Familiarity with bioinformatic software development, validation and/or usage
• Experience using electronic documentation management systems

• Knowledge of the following standard and regulation: ISO 13485:2016, IVD 98/79/EC, IVDR 2017/746, 21CFR820, IEC 62304:2006, Meddev 2.7/1 rev 4, MDCG 2020-1
• Experience in presenting documents and processes during a regulatory audit

Benefits:

• A flexible and friendly working environment with a collaborative atmosphere
• An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
• Carrer opportunities in a fast-growing company with worldwide reputation
• International and multicultural environment
• Permanent exchanges with teams of experts within the company.