DCS Senior Manager

PharmaLex is one of the largest providers of Development Consulting and Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech and MedTech industries to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch. 

We are currently looking for an experienced professional to support DCS projects and teams providing project management technical, and regulatory expertise on US drug development programs to ensure development objectives and regulatory requirements are met and compliant with applicable regulations, guidance, and laws.

PharmaLex is a proud to be an equal opportunity employer.  We respect and seek to empower each individual and support the diverse cultures, perspectives, skill, and experiences within our workforce.  We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

Key Responsibilities and Activities

• Research, interpret, and apply relevant regulations and industry guidance to inform product development/regulatory strategy and to meet client development objectives
• Advise clients on regulatory issues concerning their products and development programs; Partner with client's internal teams to assure development plans align with regulatory requirements; challenge client assumptions, when appropriate
• Work independently and collaboratively to prepare and manage project plans based on global regulatory and client product development strategy
• Coordinate team meetings with internal and external stakeholders to discuss progress on the project plan and on final client deliverables; interact with various client disciplines, such as project management, CMC, clinical, nonclinical, marketing, pharmacovigilance, quality assurance, business development and corporate management
• Ensure deliverables are completed within agreed timeline, budget, compliance requirements, service standards and adequate resources’ competency levels so that a high level of client satisfaction is achieved
• Oversee and manage client activities that are outsourced to contract manufacturers, contract research organizations, and other vendors as needed; engage in vendor identification, prepare requests for proposal, conduct competitive bid analyses, and document PLx recommendations for vendor selection.
• Represent clients at FDA, EMA, and other regulatory agency meetings
• Draft and manage regulatory submissions, annual reports, Investigator's Brochure, clinical and nonclinical study protocols, Orphan Drug Designation requests, Fast Track or Breakthrough Therapy Designation requests, Agency meeting requests, and other submissions as required.
• Keeps abreast of new and changing industry technical and regulatory requirements
• Identify scope changes in projects and manage accordingly, anticipating problems before they arise in a project
• Other duties as assigned

Required Education, Experience, Skills and Competencies

• Bachelor’s degree required, Masters or higher preferred, in a scientific or life science discipline or closely related field
• Minimum of 4 years regulatory affairs and/or drug development experience, preferably within a pharmaceutical or biotechnology company or consulting environment
• Excellent industry knowledge and familiarity with the drug development process, US regulations, ICH, FDA, and EMA guidance, and the organization of the common technical document (CTD)
• Experience in understanding and organizing complex scientific, technical and/or regulatory documents
• Strong written, verbal, and presentation communication skills; experience with negotiation and persuasion
• Strong organization, analytical, and problem-solving, and time management skills
• Strong project management skills, with an understanding of managing customer expectations
• Strong interpersonal skills and ability to lead and coordinate a multidisciplinary team
• Ability to adapt under regularly changing conditions and competing priorities
• Ability to work independently and as part of a team

Key Performance Indicators

• Attainment of yearly goals according to Supervisor
• Successful execution of client deliverables within scope and on budget
• Diligent and on-time entry of billable and nonbillable time by project code
• Adherence to PLx SOP and working instructions and timely completion of assigned trainings
• Team members’ feedback
• Client satisfaction

* This is a remote position.