Submissions Strategy Manager Job in Cambridge, Massachusetts US
SUBMISSIONS STRATEGY MANAGERCOMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.
We specialize in the nationwide recruitment of clinical trials personnel.Our client has a leading oncology drug, proven commercial capabilities, and many product candidates in varying stages of development and is seeking to add a Submissions Strategy Manager to their Regulatory Affairs team in Cambridge, MA.RESPONSIBILITIES:
Main responsibility is to take the strategy and drive the timelines for the regulatory submissions.
Responsible for Regulatory submission management and planning, working with the Regulatory Leads to develop and submit filings according to agreed upon processes and timelines.
Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management.
Identify issues that may delay product or project and recommend appropriate action to be taken.
Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology.
Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.
Prepare and maintain templates that meet Regulatory electronic submission standards.
Assist in establishing electronic submission capability, focusing on implementing the eCTD and representing Regulatory business function on technology teams
Manage compliance-related submissions and activities.
QUALIFICATIONS:
Minimum of 4 years of experience within the pharmaceutical industry
Strong project management and/or submission management experience is required.
Experience in preparing regulatory submissions (e.
g., investigator documentation, protocol amendments, etc.)
4 years Regulatory Affairs or pharmaceutical experience is required
Experience in a Regulatory Submissions organization
Working knowledge of drug development process.
Must be detail-oriented, flexible, and able to function in a multi-tasked environment with time constraints.
Excellent communication, organizational, and interpersonal skills are required.
MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
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