• Detail-Oriented
• Proactive
• Problem-Solver
• Results-Driven
• Organized
• Multi-Tasker

Parexel Regulatory Consulting is seeking a Manager, Regulatory Affairs with a "my team" mindset, a passion for motivating and developing their teams, and a willingness to roll up the sleeves to meet the Regulatory needs of our Client Partners!!

A Manager, Regulator Affairs provides leadership and direction to associates, consultants and senior consultants, actively managing employee performance and development. A manager acts as a role model and provides or organizes coaching/mentoring and feedback to direct reports. A manager provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.

Key Accountabilities:

Project Execution

• Works within a team environment or individually based on the project needs

• Provides guidance to project team members

• Works within broad project guidelines and facilitates issue and conflict resolutions

• Prioritizes own workload and may prioritize the workload of the project team to achieve the project scope and objectives

• Capitalizes on opportunities to improve project efficiency, results or team performance and proactively acts

• Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions

• Produces quality work that meets the expectations of Parexel Consulting (PC) and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met

• Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives

• Manages project engagements as a project lead (small or medium)

• Works with Project Staffing to identify and ensure appropriate resources are assigned to projects

• Regularly communicates with direct reports on the status and execution of their projects. Provides ongoing guidance and support especially with the resolution and escalation (if needed) of issues

• Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support

• Follows all required Business Operating Process (BOPs) for pre-initiate, initiate, execution, close and monitoring of projects

Staff Management

• Actively manages performance including typical HR activities for direct reports (i.e., performance management reviews, salary actions, bonuses, scorecards)

• Provides input on staff to appropriate PC Directors

• Provides applicable guidance and support to staff for staff to succeed and achieve key metrics

• Supports development plans for staff and coordinates with senior management to ensure that staff is utilized completely and appropriately to increase their expertise

• Advocates for staff to senior management to provide opportunities to expand staff skill sets

• Communicates organizational vision and values to staff

• Regularly communicates with staff to assure effective two-way information flow (i.e., business updates, project updates, staff interests, issues, and/or concerns)

• Assures Parexel policies and procedures are communicated to line personnel in alignment with their staff’s local country

Consulting Activities and Relationship Management

• Provides a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear

• Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction

• Facilitates client decision making by framing issues, presenting options, and providing objective business advice

• Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts.

• Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities

• Acts as a trusted advisor to clients and/or project team on technical and/or process issues

• Develops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers

• Interacts professionally at multiple levels including senior management within a client organization

• Successfully penetrates executive management levels or other business units within a client organization

• Facilitates clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems

• Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and results in additional business or referrals

• Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management

Business Development

• Actively prospects and leverages new business opportunities with senior client and industry contacts in collaboration with Account Management

• Generates presentations about Consulting service offerings reflecting the organization’s capability to support client needs and shares with potential clients

• Generates new or repeat business due to personal name recognition or history of client satisfaction and/or relationship

• Leverages rainmaking skills resulting in new and repeat business for Parexel. Is responsible for constant monitoring of his/her “A” list, and is expected to have continued contact with both existing and future potential clients

• Frequently participates in project scoping calls and proposal preparation

• Frequently delivers sales presentations and participates in bid defense meetings when needed.

• Consistently closes large new business opportunities

• Contributes information to support the account planning process and integrated marketing programs

Parexel-related Responsibilities

• Meets established metrics as specified in scorecard on an annual basis

• Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management

• Defines self-development activities to keep current within the industry (i.e., maintain membership in a relevant industry and/or scientific/technical association)

• Maintains cross-SBU relationships

Skills:

• Consulting skills

• Project management knowledge

• Influencing others

• Client-focused approach to work

• Networking

• Results orientation

• Business analysis

• Excellent interpersonal and intercultural communication skills, both written and verbal Teamwork and collaboration

• Critical thinking and problem-solving skills

• Holding people accountable

• Operational leadership

• Leading change

• Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:

• At least 5 years of previous people-management experience, experience managing teams of 8+ direct reports strong preferred

• Numerous years of experience in life sciences or consulting industries in a regulatory affairs focused role as a generalist or clinical/nonclinical regulatory role

• Previous consulting experience with knowledge of FSP Client Partnerships is a plus

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD)

Based upon the location of this individual's team, an East Coast candidate is highly preferred.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.