Clinical Scientist, Dermatology & Rheumatology CRO, Canada

Indero•Montreal, QC

17h•Remote

About The Position

The Clinical Scientist is responsible for medical writing activities at Indero. The individual will author or contribute to 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, enjoy learning continuously and keeping yourself informed, and are motivated by having an impact within a growing company with momentum.

Requirements

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.

Nice To Haves

PhD is an asset.

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.