Senior Clinical Scientist / Scientifique clinique principal, Canada, remote

About this role

Description
The senior clinical scientist is responsible for authoring or contributing to development of clinical and regulatory documents (synopsis, study protocols, statistical analysis plans, clinical study reports), as well as scientific publications. The senior clinical scientist supports the internal team by providing scientific expertise during proposal stage for new opportunities, as well as during study conduct. In addition, the senior clinical scientist assists the team to deliver commitments on time, within budget and in compliance to SOPs and regulations, and provides training and mentoring for junior staff.
The senior clinical scientist may also participate in cross-functional internal projects to support different process improvement initiatives within the company.
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
More specifically, the senior clinical scientist:

• Contributes to study design and writes/reviews clinical study protocols;

• Reviews informed consent forms;

• Reviews statistical analysis plans and 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;

• Prepares and reviews training material for the scientific team and for the whole company (e.g. Dermatology training program, new therapeutic areas);

• Is accountable for own medical writing deliverables, including quality, stakeholder communication, resolution of project issues, and timeline management;

• Provides documents with high quality in terms of scientific content, organization, clarity, accuracy, format and consistency;

• Provides scientific expertise during study conduct on assigned projects;

• Acts as mentor and provides training for new staff or for more junior staff;

• Performs quality control review of documents prepared by other team members;

• Contributes to study design and writes/reviews clinical study protocols;

• Reviews informed consent forms;

• Reviews statistical analysis plans and 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;

• Prepares and reviews training material for the scientific team and for the whole company (e.g. Dermatology training program, new therapeutic areas);

• Is accountable for own medical writing deliverables, including quality, stakeholder communication, resolution of project issues, and timeline management;

• Provides documents of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency;

• Provides scientific expertise during study conduct on assigned projects;

• Acts as mentor and provides training for new staff or for more junior staff;

• Performs quality control review of documents prepared by other team members;

• Assists the scientific affairs team to deliver commitments on time (e.g. planning projects deliverability junior team members), within budget, and in compliance to SOPs and regulations;

• Provides therapeutic and medical writing expertise;

• Provides input in organizational improvements and actively participates in implementation of new processes and/or procedures;

• May participate in QA or client audit as subject matter expert for the scientific team;

• Supports the business development department by writing/reviewing study synopsis for proposals, by developing scientific content for Bid defense meeting, by providing scientific expertise during meeting with sponsors or by answering questions received from sponsors;

• May review assumptions and budget for scientific affairs scope of work for new opportunities during RFP process.

• Maintains familiarity with relevant current industry practices and regulatory requirements and guidelines; actively participates in clinical development consulting services by providing scientific support and medical writing for pre-IND and IND submission;

• Provides scientific expertise in cross-functional projects and may also act as project lead in such initiative to align with the company strategic objectives.

Employees may be assigned other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
IDEAL PROFILE

Education

• MSc in a related field of study or combination of relevant education and work experience; PhD or MD is an asset;
Experience

• Minimum of 6 years of clinical research experience; with 3 years in writing clinical/regulatory documents (such as study protocol and clinical study reports) and analyzing and reporting study data in CRO/pharmaceutical industry;
Knowledge and skills

• In-depth knowledge of drug development process and applicable regulatory requirements;

• Strong English communication skills; advanced English writing skills;

• Strong proficiency of Word, Excel, and Power Point, with advanced skills formatting large documents;

• Ability to handle varied and multiple tasks, and prioritize workload;

• Has excellent attention to detail;

• Client-focused attitude;

• Team player with excellent interpersonal skills;

• Quick learner, good adaptability and versatile;

• Leadership and ability to positively influence others;

• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA)…