manager, Regulatory services (editing)Certara

Job Overview:
The Regulatory Services Manager (RSM) supports the Regulatory Services organization by managing a team of direct reports (5-6 employees) in matters of compliance, oversight and line management, coaching and mentoring, onboarding and development, ongoing billable activities, retention, and employee engagement. Our people are our most valuable asset. The RSM is a key contributor to developing our people and providing opportunities to learn, improve current skills, and remain committed to our overall mission. The RSM will still contribute subject matter expertise to the regulatory services provided to our clients but your main responsibility will be to support the staff in development of the final quality work.
Responsibilities:
This role has dual responsibilities as a contributor to leading and managing authorship for a variety of written deliverables across various therapeutic areas as well as supporting staff development and corporate positioning.
Proactively and effectively communicate to all stakeholders to drive seamless professional development and optimal resource utilization
Provide administrative direction, provide solutions to obstacles of success, consistently encourage employees to learn new skills, guide professional development and recognize performance
Take steps to identify employee skills and work to strengthen those skills while developing new skills
Strive to hire top talent and reduce undesirable turnover and learn to identify factors that help engage staff
Understand the value of coaching as a key tool to support personal development
Monitor performance of work product and administrative responsibilities and address non-compliance
Proactively alert senior management of issues requiring intervention, communication, or additional support
Conduct effective and regular 1:1 meetings and perform expedient follow-up (as applicable) and performance assessment
Education, Experience, Training, and Knowledge:
BS degree in life sciences or equivalent
2+ years of regulatory writing experience or equivalent experience with nonclinical, clinical, CMC, or pharmacovigilance related documentation
Proven leadership ability working with a team of high-level, high-intensity writers, editors, publishers and project managers at a variety of experience levels
Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
Skills & Abilities:
Ability to make independent decisions with the company and staff's best interests in mind
Ability to earn the respect of other company leaders
Demonstrated ability to manage and oversee projects and/or resourcing for projects
Ability to provide high-quality customer service and follow-through on all assignments
Professional, personable demeanor
Strong interest in a writing/editing role but with a stronger interest in leading others with those interests
Show basic understanding of communication theory (listening, summarizing, questioning etc.) and effective presentation of internal and external content
Approachable and supportive and willing to listen and understand employee concerns
Recognize value in sharing information; thinks about others and considers available sources of input to accomplish objectives
Responds to requests to work in a collaborative manner by providing input when required
Understands impact of own work or behavior on colleagues / other areas of the business, respects views that are different from own.
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Certara

Makati City, Metro Manila
Permanent
Full-time