Drug Safety Manager

Leaderboard

Remote, Remote

January 2022

Job Title: Drug Safety Manager

Leaderboard Branding, a Fingerpaint company, is a global naming and branding firm that delivers strategic insights and world-class creativity to every client, on every engagement. Built on the tenets of put people first and take pride in your work, we strive to develop strong and strategic partnerships with healthcare and biopharma companies. Leaderboard is seeking passionate, talented people, excited about branding, to become significant contributors to our company and to the future of the branding industry.

Overview of the Role:

The key areas of responsibilities for the Drug Safety Manager role are as follows:

  • Support and lead drug safety projects including risk assessments, scientific vocabulary development, trade name and nonproprietary name development, package & label development, and logo development engagements
  • Contribute to the review and execution of deliverables from a drug safety and regulatory lens
  • Participate in refining the drug safety best practices and the development of new drug safety deliverables
  • Provide insight and answers to clinical questions and act as a resource for regulatory and drug safety knowledge
  • Guide best practices on regulatory research and assist in interpreting findings
  • Support the development of regulatory submission deliverables and adjust process to ensure that all deliverables align with published regulatory guidance
  • Provide internal training in appropriate areas of expertise to other departments
  • Serve as a subject matter expert and contribute regularly to external insights

Ideal Candidate:

  • Demonstrated ability to communicate, present and influence credibly and effectively at all levels of the organization, including executive and C-level
  • Energy, enthusiasm and the ability to work under pressure to meet deadlines and demanding targets
  • Comfortable speaking/presenting to industry clients as lead or support (online and in-person)
     

Requested Background and Experience:

  • BS Pharmacy or PharmD degree with industry experience related to our core services (2-3 years minimum) or BS Science with advanced regulatory degree (i.e., Masters in Regulatory Affairs) and has worked in industry (2-3 years)
  • Drug safety experience (fellowship, classes, med safety programs) in clinical setting is ideal
  • Comprehensive regulatory knowledge and understanding of pharmaceutical product submission and approval
  • Ability to be agile due to involvement in multiple projects simultaneously

 

About Leaderboard Branding:

Leaderboard Branding was built with a better way in mind. We partner with clients to give them the freedom to explore what their brands could be. Leaderboard Branding is committed to supporting and encouraging diversity, inclusion, and respect. Leaderboard offers competitive salaries and an excellent benefits package that includes fully paid medical insurance premiums for employees and their dependents and a matching 401k plan. Learn more at leaderboardbranding.com.