Sr. Specialist, Regulatory Affairs

Company: Merck Sharp &Dohme LLC
Location: Cambridge
Posted on: May 27, 2023

Job Description:

Sr. Specialist, Regulatory Affairs-Cambridge, MA: work closely w/various stakeholders to drive identification, planning, resourcing, execution, and management of regulatory affairs activities that deliver high quality and timely regulatory and safety submissions. Independently mange regulatory and safety submission projects across all submission types. REQD: Bachelors degree in Regulatory Affairs or Pharmaceutical Science plus 2 yrs working exp. w/in healthcare/consumer care industry project management, regulatory affairs, &/or pharmcovigilnce/risk management function. Exp. w/managing successful delivery of regulatory submissions reqd. Must be technically skilled in project management methodologies (e.g. PMP). Ability to lead by influence & work effectively in matrix organizational structures; effective at energizing others, establishing clear goals, delegating responsibility, mentoring & coaching w/in team setting; well developed & effective team facilitating and leadership skills; ability to establish cooperative team environments; ability to understand details, keep overall "big picture" view of projects & strategies. Telecommuting permitted. Must have proof of legal authority to work in US. Apply at Merck Sharp & Dohme LLC's career site: www.merck.com/careers, create profile & submit CV for JobReq#R235209. EOE. Merck Sharp & Dohme LLC is subsidiary of Merck & Co., Inc.

Keywords: Merck Sharp &Dohme LLC, Cambridge , Sr. Specialist, Regulatory Affairs, Other , Cambridge, Massachusetts