Medical Safety Writer

Chiltern International is a privately held, well established global clinical research organization with offices throughout Europe and North America. We were established in 1982 and have served pharmaceutical, biotechnology, and device companies in over 38 countries worldwide. Due to our continued growth, Chiltern is seeking a highly motivated individual to join us as a Medical Safety Writer located in Chicago.

The qualified candidate will have a Bachelors degree in a life science or a related field. In addition, we require a minimum of two years experience in a pharmaceutical, biotech or CRO environment.

 

 

Essential job functions include: Write and prepare safety regulatory documents and submissions.  Assist in the management of writing and research project timeliness.  Assist with creation and maintenance of standardized departmental procedures for writing and processing safety regulatory submission documents.  Collaborate with safety and medical reviewers on safety related issues relative to writing projects.  Participate in ongoing safety data review and analysis for products in designated therapeutic areas.  Participate in risk management activities as applicable to writing and research projects.  Assist in the training of other writing team members.

 

 

Required skills and abilities include: Knowledge of safety reporting regulations.  Experience wtih preparation of regulatory submission documents.  Experience with commercial databases.  Experience with coding dictionaries (MedDRA, WHOART, COSTART, etc.)  Excellent analytical and problem solving skills.  Good oral and written communication skills, good clinical knowledge, good computer literacy, and experience working in a team environment.

 

 

Chiltern's unique corporate culture encourages a healthy balance of personal life and work. We offer an excellent salary and benefit package to include medical, dental, vision, company matching 401K, excellent vacation & holiday, and employee incentives. If you have the experience required and feel you are the dynamic person we are looking for, please forward your resume in a Word document via email to uscirs@chiltern.com  


 

 

View Chiltern's website at www.Chiltern.com