Sr. Manager, Regulatory Services

Montreal, Quebec, ca
Company: Certara
Category:
Published on 2021-04-12 17:26:38

Responsibilities:

This role has dual responsibilities  as a major 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 across the business 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, recognize good and lagging performance, giving timely, specific and constructive feedback
  • Take steps to identify employee skills and work to strengthen those skills while developing new skills; have career discussions with employees to help them achieve the right skills to meet those objectives using a mix of silence, questioning and challenge
  • Strive to hire top talent and reduce undesirable turnover and learn to identify factors that help engage staff
  • Maintain strong understanding of corporate strategy, financial and structural processes and communicate appropriate information in a timely manner
  • 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
  • Communicate organizational changes, support employees through times of ambiguity or stressful workloads
  • Education, Experience, Training, and Knowledge:

  • BS/BA degree in relevant field, PhD, MD or PharmD preferred
  • 3-5 years of regulatory writing experience as a lead author on multiple clinical documents such as Protocols, CSRs, ISS, ISE, and clinical sections of submission documentation. 
  • Extensive knowledge of drug development and global regulatory requirements and submissions process 
  • Understand regulatory requirements for different phases of development and different regulatory pathways
  • Knowledge of global health authority requirements
  • Prior experience managing employees
  • Skills & Abilities:

  • Understand how coaching differs from other helping behaviors, such as counseling and mentoring
  • Understands when own skills are not sufficient and refers an individual to a more experienced coach
  • Proven leadership ability working with a team of high-level, high-intensity writers and editors at a variety of experience levels 
  • 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 
  • Approachable and supportive and willing to listen and understand employee concerns
  • Effectively build productive and cooperative team working relationships with colleagues; Encourage and actively seek the views of others on ways to approach tasks and resolve problems; always strive to support a positive team spirit
  • 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.

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