The Clinical Scientist is responsible for medical writing activities at Innovaderm. 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.
• 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.

IDEAL PROFILE

Education 

• MSc relevant to life sciences; PhD is an asset;

Experience 

• Minimum of 5 years writing clinical/regulatory documents (such as study protocol and clinical study reports) and analyzing and reporting study data in CRO/pharmaceutical industry;
• Experience analyzing and reporting on study data.

Knowledge and skills

• 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;
• 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.

OUR COMPANY

The work environment

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

In this role, you will be eligible for the following perks: 

• Flexible work schedule
• Permanent full-time position
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
• Possibility of working from home or our office in Montreal in accordance with company policies and public health directives
• Ongoing learning and development

Work location

The successful candidate for this position is given the option to work from home anywhere in Canada, or from our headquarters in Montreal (in accordance with company policies and public health directives). 

Occasional visits to our Montreal headquarters may be required or encouraged

Covid-19 vaccination policy: The health and safety of all is important to us. In accordance with the applicable vaccination policy, Innovaderm demands that all employees present at its offices as well as all client and vendor sites (including clinical sites) be adequately vaccinated, under reserve of exemptions related to adaptation requirements prescribed by law. 

About Innovaderm

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, Innovaderm continues to grow and expand in North America and Europe.

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

Innovaderm only accepts applicants who can legally work in Canada.