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

Emergent BioSolutions is currently seeking a Scientist, Clinical Research. The successful candidate will have an advanced degree in life sciences (Ph.D. preferred), 3-5 years of experience as a Clinical Research Scientist and excellent knowledge of Health Canada, FDA, other international regulations and ICH-GCP guidelines. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

THE COMPANY

Emergent BioSolutions is dedicated to one simple missionto 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 developmentand 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:

• Qualified candidates will have an advanced degree in life sciences (Ph.D. preferred) or medicine.
• 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.

Interested?Please visitwww.emergentbiosolutions<>.comunder the career section to apply today!

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy<>.