Summary of Position

The (Contractor) Regulatory Affairs Technical Writer will facilitate success of key regulatory projects by coordinating regulatory activities, deliverables, and submission content across Regulatory Affairs Staff and cross functional teams. In this capacity, the individual will work to improve organization and tracking of internal department projects and deliverables that drive success against the project timeline and FDA approval. Under general supervision, this position will also facilitate success of key company projects by supporting department Director and Managers in tracking project action items, milestones, and deliverables across functional areas. Effective communication with the international department as well as across multiple languages is essential to this position.

Additional responsibilities will include facilitating regulatory data flow.

Work Schedule: Mon - Friday 8am - 4:30pm

Essential Functions

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, RIC/S, ISO, USP, NRC, cGMP, etc.)
• Manage project submissions as assigned by Director Regulatory Affairs including department work process.
• Manage key projects, planning, timing, and execution for submission, approval, and launch.
• Maintain project database for tracking individual and department project deliverables.
• Manage incoming requests through logging, assigning, tracking, working with RA staff to manage complexity and difficulty, and maintain department metrics.
• Maintain database and tracking of key department deliverables
• Facilitate use of regulatory electronic submission software to allow more efficient compilation process.
• Collaborate with RA staff assigned to projects in order to prospectively mitigate RA resource conflicts.
• Manage multiple, sometimes conflicting priorities.
• Maintain and track deliverables
• Share expertise with peers.
• Other duties as assigned or requested by Director Regulatory Affairs.
• Apply expertise to cross functional departments and provide proper leadership.
• Establish and review Global RA priorities as they relate to department and company goals and objectives.

Requirements

• Bachelor's Degree in technical discipline, pharmaceutical industry, or related life science preferred.
• Project Management Experience - Certification Preferred
• 3 or more years Regulatory Affairs support of submission content, compilation, or publishing
• 3 or more years Project Management experience in Pharmaceutical or Heath related industry
• Ability to facilitate decision making specific content expertise may reside with team members
• Experience in Project set-up/initiation, executions, and completion within established timeframes
• Building Effective work streams and work process
• Team Member and Team Leader experience on cross functional teams.
• Strong evidence and mastery of being a "Team Contributor" Experience with regulations associated with Investigational, New Chemical Entity, and Generic drug applications preferred.
• Experience with International Cross Functional Teams
• Attention to detail and overall drug application quality and internal consistency.
• Strong decision making skills
• Excellent written and oral communications skills.
• Strong interpersonal, and negotiation skills, conflict management, priority setting, strategic agility, building effective teams, managing vision and purpose.
• Proficiency in computer skills (MS Office Project, Access. Excel, Document Management Systems)

Working Conditions:

• This position will work in typical office conditions with extensive time using computer equipment.
• Must possess good hand-eye coordination; close attention to detail required.
• Willingness to work in a team-based environment.
• Willingness to travel to and work in manufacturing facilities.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Willingness to complete safety training within allotted timeframes.
• The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime is sometimes required.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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