[Hiring] Clinical Scientist @Indero

Role Description

The Clinical Scientist is responsible for medical writing activities at Innovaderm. The individual will author or contribute to the development of clinical and regulatory documents (synopsis, study protocols, statistical analysis plans, clinical study reports), as well as scientific publications.

This role will be perfect for you if:

• You are a strong medical writer with demonstrated ability to produce high-quality scientific documents to support clinical research.
• You enjoy learning continuously and keeping yourself informed.
• Having an impact within a growing company with momentum motivates you.

Responsibilities

• Is accountable for own medical writing deliverables, including quality, stakeholder communication, resolution of project issues, and timeline management.
• Collaborates to clinical development of Phase 1/First-in-Man studies, Proof of Concept (POC) trials, Phase 2b – 3 studies, and Phase 4/registry trials.
• Contributes to study design and writes/reviews clinical study protocols/amendments.
• Reviews informed consent/assent forms, study reference manuals, statistical analysis plans, and mock shells of statistical tables/figures/listings.
• Reviews, analyzes, and interprets study data based upon scientific expertise and industry standard practices.
• Writes/reviews narratives and clinical study reports.
• Prepares scientific abstracts, posters, and manuscripts.
• Performs on-line literature searches.
• Provides documents with high quality in terms of scientific content, organization, clarity, accuracy, format and consistency.
• May perform quality control review of documents prepared by other team members.
• Participates in process improvement efforts of the department.

Qualifications

• MSc in life sciences; PhD is an asset.
• Experience in writing clinical/regulatory documents such as study protocols and clinical study reports.
• Experience analyzing and reporting on study data.
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
• Good knowledge of drug development process.
• Advanced English writing skills; strong English communication skills; French is an asset.
• Strong proficiency of Word.
• Ability to handle varied and multiple tasks, organize own work, and prioritize workload.
• Has excellent attention to detail.
• Client-focused attitude.
• Quick learner, good adaptability, and versatile.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Ongoing learning and development.

Company Description

Indero, formerly Innovaderm, is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Europe.