Regulatory CMC Technical Operations (v631)

  • Contract Duration: 6-12 months, Onsite Hybrid
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is looking for a qualified candidate to fill a contractual position for a Regulatory CMC Technical Operations with one of our global pharmaceutical clients. This is a TEMP to PERM role. Project management skills are a MUST! Pharma experienced is REQUIRED. This is a remote position but candidates will be asked to come into the office occasionally.

Responsibilities of a Regulatory CMC Technical Operations:

  • Exhibits high degree of computer knowledge and word processing skills to ensure proper document formatting creatively, accurately, and efficiently in support of regulatory filings
  • Knowledge and competence with multiple software suites and systems, including Microsoft Office
  • Demonstrates proficiency in task management, including working with key stakeholders to define reasonable timelines
  • Meets negotiated deadlines, demonstrating initiative and independence in completing tasks
  • Frequently meets deadlines and anticipates needs; consistently recognizes ways to offer additional support, completing tasks to satisfaction
  • Uses good judgment in setting work priorities, planning and organizing workload during many interruptions
  • Demonstrates ability to work with deadlines and handles emergent situations calmly
  • Encourages team cooperation and fosters the development of trust
  • Actively facilitates and supports team decisions
  • Goes beyond responsibilities to help teams accomplish tasks and goals
  • Demonstrates poise and flexibility in a fast paced and dynamic environment
  • Able to prioritize and manage multiple projects simultaneously, and follows through on issues in a timely manner

Required of a Regulatory CMC Technical Operations:

  • Strong organizational skills
  • Strong written and verbal communication skills with demonstrated high proficiency for correct spelling, grammar, tone and syntax
  • A team player who is helpful and constructive, always interested in helping others succeed
  • Ability to navigate and be successful in a fast-paced, highly matrixed, dynamic work environment
  • Can work with minimal supervision and takes initiative
  • Experienced in project management, including maintaining timelines, task trackers (Smartsheet), etc.
  • Experienced with a controlled document management system (e.g. Veeva, PleaseReview) and workflows
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Planner, Project, etc), including formatting and extensive word processing
  • Experienced with StartingPoint templates a plus
  • Experienced in SharePoint
  • Legally authorized to work in the US

Preferred of a Regulatory CMC Technical Operations

  • Background in small biotech or pharma support
  • Bachelor’s degree in science or business with 1- 4 years working in pharmaceutical industry or Master’s degree in science or other professional area with 1-2 years of experience
Upload your resume here.

Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team