Boehringer Ingelheim Regulatory Submission Specialist (6 month contract) Full Time in Burlington, ON

Overview

Boehringer Ingelheim

Branch Burlington ON CA

Position:
Regulatory Submission Specialist (6 month contract)
Location:
Burlington, ON

The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for…

Responsible for managing and performing the activities related to the compilation and archiving of high quality regulatory submissions (both hard and electronic format) in a timely manner.
Responsibilities:

1. In co- operation with the DRA Project Manager/Associate, to manage and perform the activities related to the compilation and archiving of all types of regulatory submissions which are formatted according to Health Canada requirements, in an agreed upon time frame. Currently, all regulatory submissions must be compiled and archived in both paper and electronic format according to stringent Regulatory and BI Corporate conditions.

Key responsibilities include :

§ Independently developing a pre-compilation plan and timelines for preparing the submission modules;

§ Assessing and prioritizing workload to ensure that all deadlines are met;

§ Ensuring high quality submissions by compiling submissions according to current authority regulations/guidelines;

§ Independently performing all post-compilation activities in Documentum (preparation of Virtual documents and archiving).

§ Providing support to DRA Project Manager/Associate by input of required data into Corporate and local data systems (e.g. CPD, RSPP, CCDS tracking) within timelines specified by Corporate Office or local Management.

2. Responsible for the development, implementation, maintenance and enhancement of both hard copy and electronic document/submission management and filing systems to support daily activities.

3. Responsible for maintaining and enhancing expertise in Documentum in order to provide specialized technical service to DRA team members and Medical Department.

Qualifications: · Thorough knowledge of the Canadian Health Authorities’ Guidelines/Policies regarding the proper format of regulatory submissions.
· Significant experience in the Pharmaceutical Industry in compiling/formatting all types of regulatory submissions.
· Advanced knowledge of electronic filing and archiving systems in Documentum as well as other business office software applications (e.g Microsoft Word, Outlook).
· Excellent task/project management skills, i.e. good planning , organizational and time management skills, good communication skills, ability to work independently or in a team environment, to complete work within strict deadlines, and attention to detail.
Our Culture:

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 145 affiliates and a total of more than 47,500 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of its net sales.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 600 people across Canada.

For more information please visit www.boehringer-ingelheim.ca

Applications for this position will be accepted until 18/2/2017

Job – Medicine/Regulatory Affairs
Primary Location - Americas-CA-Ontario-Burlington

Organization - CN-Boehringer Ingelheim Canada Ltd/Ltee
Schedule - Full-time