Job Description :
Responsibilities may include the following and other duties may be assigned. Analyzes proposed changes of marketing materials to determine appropriate approval requirements. Coordinates records for change control. Coordinates changes with marketing, engineering, regulatory affairs, and clinical. Ensures that requirements are implemented and reviews changes to ensure compliance with configuration management policies. Routes the material in the system of record (e.g., Documentum) and ensures timely completion from cross-functional participants. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. The majority of time is spent delivering and overseeing the projects while and adhering to policies.
Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making. Requires practical knowledge and demonstrated competence within project management (small scale Requires a University degree or a minimum of 2 years of relevant experience.
Top must haves:
-Technical documentation knowledge or marketing communication management
-Documentation control experience in regulated environment
BASIC QUALIFICATIONS:
? Bachelor''s Degree OR
? 2+ years of experience in marketing communication, configuration assurance, quality, or regulatory
DESIRED/PREFERRED QUALIFICATIONS (optional):
? Experience with and understanding of quality systems, FDA QSR.
? Ability to facilitate working sessions on cross-functional material review.
? Skilled in tasks associated with document handling, archiving and change management.
? Project management skills needed to plan and manage implementation plan.
? Ability to file and organize records.
? Strong attention to detail and accuracy.