Scientist, Clinical Research

3 days ago

Winnipeg, Canada Emergent Biosolutions Full time

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

SCIENTIST, CLINICAL RESEARCH

THE COMPANY
Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.
As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.
We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

THE OPPORTUNITY
The Clinical Research Scientist is responsible for generation of clinical development plans and study protocols, analysis of clinical data and writing clinical study reports and providing scientific consultation and expertise throughout clinical product development.

ESSENTIAL FUNCTIONS
Review of scientific and medical literature relevant to product therapeutic areas.
Lead departmental team in the design of clinical programs, concept sheets and proposals to support clinical development.
Development and writing of investigator brochures and product labels/prescribing information.
Interaction with scientific and medical experts and opinion leaders and study investigators regarding the development of clinical study protocols and programs.
Lead departmental team in design and writing of clinical study protocols to ensure scientific rationale and operational conduct.
Interaction with biostatisticians to analyze and compile clinical data and write clinical study reports.
Preparation of clinical study reports, summaries and supporting documents for regulatory submissions.
Presentation of clinical plans, results and summaries to regulatory authorities including the FDA, Health Canada and internationally.
Interaction with Clinical Operations, Data Management and Pharmacovigilance units during clinical study lifecycle.
Interaction with Regulatory Affairs and Business Development during product development and licensure.
Identification and oversight of Clinical Research consultants contracted to provide expertise within product development programs.
Participation in the planning and generation of regulatory strategy documents.
Mentoring and guiding team members to further their professional growth.
Build strategic working relationships with other working groups/departments to achieve corporate goals.
Participate in development and continuous improvement of departmental processes and workflows.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

**EDUCATION, EXPERIENCE & SKILLS**:
At least 3-5 years experience as a Clinical Research Scientist.
Excellent written and oral communication skills are required.
Excellent knowledge of Health Canada, FDA, other international regulations and ICH-GCP guidelines required.
Ability to communicate and present complex scientific and clinical issues to management and regulatory authorities.
Excellent computer skills, with ability to work within core templates designed for regulatory submissions, basic MS software, search engines for literature reviews, navigating regulatory websites.

**ADDITIONAL REQUIREMENTS**:
Citizenship/Permanent Resident or Valid Work Permit.
Successful Completion of a Criminal Record Check.

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