FRESENIUS MEDICAL CENTER
Dir Global RA eCTD Operations
FRESENIUS MEDICAL CENTER, Watertown, Massachusetts, us, 02472
PURPOSE AND SCOPE:
Oversees all regulatory activities for new and mature products to ensure alignment and compliance with local and regional requirements as well as with company policies. Develops and implements strategies systems designed to ensure compliance with electronic submission requirements and document management systems. Ensures timely preparation of organized and scientifically valid applications. Provides expertise in translating regulatory requirements into practical, workable plans.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Manage the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce.
Oversees the development and implementation of systems and procedures used to support regulatory submission (drugs and devices) and publishing activities.
Oversees the establishment and maintenance of an archiving/document management system.
Manages document producing, publishing and tracking for company regulatory submissions and submissions-complaint documents in support of active INDs, (e.g. clinical trial applications, IND/ODA annual reports, amendments) in the electronic format (eCTD and eFiling).
Develops, implements and maintains various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions.
Provides training to department and external groups.
Evaluates and provides input for new department technologies and collaborates with intra-departmental resources to ensure adherence to infrastructure standards.
Compiles, publishes, QC and validates documents for FDA submission.
Troubleshoots document issues in MS Word and Adobe Acrobat.
Provides advance editing and formatting support.
Manages the transition from legacy to electronic submissions.
Coordinates with regulatory staff to compile regulatory submissions.
Ensures that all required documents are received and formatted appropriately and in a timely manner.
Maintains current knowledge of new regulatory guidelines and policies to support company procedures. Remains current with electronic submission requirements and prepares for future initiatives and requirements.
Generally manages department budget and day-to-day functions. Develops budgets, schedules and performance standards. Exercises supervision in terms of costs, methods, and staffing.
Interacts frequently with internal departments and external customers/vendors; particularly in problem resolution. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
Provide technical guidance.
Assist with various projects as assigned.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISION:
May be responsible for the direct supervision of various levels of Regulatory Affairs Operations staff.
EDUCATION:
Bachelor’s Degree required; Advanced Degree desirable.
EXPERIENCE AND REQUIRED SKILLS:
6 – 8 years’ related experience.
3+ years’ experience as a Manager preferred.
Demonstrated ability to manage one or more departments.
Strong computer skills and highly proficient in MS Office applications and Adobe Acrobat (version 5.0 or higher).
Hands on experience with document management systems.
Strong knowledge of EDM, RIM and electronic publishing software preferred. Must have experience with electronic submissions, specifically eCTD and eFiling.
Have proven ability to manage regulatory submissions, with the ability to successfully manage projects to deadlines.
Expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines.
Outstanding interpersonal and communication (written and verbal) skills.
Strong software troubleshooting skills highly desirable.
Detail oriented; ability work under deadlines; strong organizational skills required.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
Oversees all regulatory activities for new and mature products to ensure alignment and compliance with local and regional requirements as well as with company policies. Develops and implements strategies systems designed to ensure compliance with electronic submission requirements and document management systems. Ensures timely preparation of organized and scientifically valid applications. Provides expertise in translating regulatory requirements into practical, workable plans.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Manage the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce.
Oversees the development and implementation of systems and procedures used to support regulatory submission (drugs and devices) and publishing activities.
Oversees the establishment and maintenance of an archiving/document management system.
Manages document producing, publishing and tracking for company regulatory submissions and submissions-complaint documents in support of active INDs, (e.g. clinical trial applications, IND/ODA annual reports, amendments) in the electronic format (eCTD and eFiling).
Develops, implements and maintains various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions.
Provides training to department and external groups.
Evaluates and provides input for new department technologies and collaborates with intra-departmental resources to ensure adherence to infrastructure standards.
Compiles, publishes, QC and validates documents for FDA submission.
Troubleshoots document issues in MS Word and Adobe Acrobat.
Provides advance editing and formatting support.
Manages the transition from legacy to electronic submissions.
Coordinates with regulatory staff to compile regulatory submissions.
Ensures that all required documents are received and formatted appropriately and in a timely manner.
Maintains current knowledge of new regulatory guidelines and policies to support company procedures. Remains current with electronic submission requirements and prepares for future initiatives and requirements.
Generally manages department budget and day-to-day functions. Develops budgets, schedules and performance standards. Exercises supervision in terms of costs, methods, and staffing.
Interacts frequently with internal departments and external customers/vendors; particularly in problem resolution. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
Provide technical guidance.
Assist with various projects as assigned.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISION:
May be responsible for the direct supervision of various levels of Regulatory Affairs Operations staff.
EDUCATION:
Bachelor’s Degree required; Advanced Degree desirable.
EXPERIENCE AND REQUIRED SKILLS:
6 – 8 years’ related experience.
3+ years’ experience as a Manager preferred.
Demonstrated ability to manage one or more departments.
Strong computer skills and highly proficient in MS Office applications and Adobe Acrobat (version 5.0 or higher).
Hands on experience with document management systems.
Strong knowledge of EDM, RIM and electronic publishing software preferred. Must have experience with electronic submissions, specifically eCTD and eFiling.
Have proven ability to manage regulatory submissions, with the ability to successfully manage projects to deadlines.
Expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines.
Outstanding interpersonal and communication (written and verbal) skills.
Strong software troubleshooting skills highly desirable.
Detail oriented; ability work under deadlines; strong organizational skills required.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.