Auftragsdetails

Group Head, Regulatory CMC ATMP - propharma group

Datum der Veröffentlichung: Mar 04, 2023
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Auftragsdetails

  • Ort:
    London, England, United Kingdom
  • Gesellschaft:
  • Typ:
    Full Time/Permanent
  • Shift:
    First Shift (Day)
  • Karrierelevel:
    Experienced Professional
  • Positionen:
    4
  • Erfahrung:
    3 Year
  • Geschlecht:
    Keine Präferenz
  • Grad:
    Bachelors
  • Vorher bewerben:
    Nov 30, 2023

Job Summary

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.


The Group Head, ATMP CMC is the proactive leader of a team of Consultants and Subject Matter Experts in European Regulatory Development. They will actively contribute towards the achievement of company objectives by effectively managing their team, providing expertise to clients and colleagues.

Detailed Description

The Group Head will also take the lead in managing projects, ensure proper delegation of tasks across the project team and a timely delivery of projects. They should be able to sustain and increase knowledge of staff members and provides operational and functional direction to project members, focusing on mentorship of less experienced team members.

 

Drives business by supporting client relationships and expanding services:

  • Identifies and delivers ideas and innovative solutions to benefit the client and ProPharma Group business.
  • Supports account and negotiation talks with (potential) clients.
  • Builds and maintains a strong industry network.
  • Identifies upselling & cross-selling opportunities and takes the necessary steps to ensure that the opportunities are supported.
  • Proactively communicates with existing clients on a regular basis to provide an update on project status, address needs, identify opportunities and ensure client satisfaction.

 

Operations Management:

  • Translates company goals into team and individual goals.
  • Ensures ongoing and planned projects are adequately staffed and manage resource utilization within the team effectively.
  • Ensures that the day-to-day activities within the team are running smoothly and deviations/bottlenecks are addressed and taken care of.
  • Monitors team and individual performance and initiates actions to strengthen results

 

Realizing Financial Targets:

  • Works together with Business Development in the acquisition of projects from existing or new clients to ensure the team is fully booked and there is opportunity for growth.
  • Collaborates effectively together with Business Development to develop proposals and contracts and provide expertise (both from self as well as team) needed to win projects.
  • Responsible for team utilization performance. Ensure that the performance is in alignment with (or exceeds) the budgeted targets.

 

Manages and develops their respective team:

  • Manages/oversees a group of Consultants and Subject Matter Experts.
  • Drives the recruitment, hiring and induction of new team members for the respective teams.
  • Prepares the annual performance management plan with the team members, conducts mid-year & end-year review appraisals and documents results in a timely manner.
  • Ensures that all team members understand team objectives and work together to achieve them.
  • Responsible for the development of the team.
  • Promotes and supports effective team working through good communication.
  • Resolves team issues and roadblocks in a professional manner to ensure minimal impact on the workflow.
  • Provides support, knowledge, and training to team members to build and improve skills and improve overall performance.
  • Provides effective and constructive feedback on a regular basis.
  • Continues to self-develop and stay up to date on market regulations/ laws, and trends.

 

Act as adviser:

  • Surveys and analyses problems, wishes and needs of the client regarding various areas of interest.
  • Advises the client regarding various areas of attention. Searches together for a fitting solution to the problem.
  • Identifies developments in the fields of work, translates these to new solutions for the client and advises about these.
  • Makes proposals that contribute to the achievement of organizational targets.

 

Developing and realizing projects:

  • Analyses the requirements, wishes, and needs at the client's request and translates these to the preconditions for the plan of action.
  • Supports Project Management with the formulation of a plan of action including time, quality, budget, information, organization, and safety criteria and presents these to the client for approval.
  • Supports the determination of the composition of the project team and takes care of an involved, well-functioning and informed project team. Settles conflicts if necessary.
  • Realises the plan of action and monitors the execution of the project based on the determined criteria.

 

Building and maintaining a network:

  • Positions the organization in the market as a logical partner concerning services in the area of ProPharma Group's services.
  • Maintains relationships with existing clients so that this leads to broadening or intensifying the relationship.
  • Contributes to the acquisition of assignments. Assesses the needs of (potential) clients and translates these to services that can be provided by the organization.
  • Identifies opportunities leading to new assignments and informs managers in time about possibilities and developments, both at clients specifically and in the market in general.
  • Takes care of internal and external publications and presentations.

 

Developing and organizing knowledge and infrastructure:

  • Takes notice of articles and books and follows new media and relevant organizations regarding developments/insights in the area of attention.
  • Tunes the requirements to the area of attention and the implications regarding (existing or new) activities with colleagues.
  • Makes the translation to possible acquisition, development of methods/techniques or extension of knowledge and skills.

 

Developing, executing, and evaluating trainings:

  • Identifies and surveys the demand for trainings within the organization.
  • Plans and organizes the deployment of training programmes in the own area of attention; usually gives trainings internally, sometimes externally as well.
  • Organizes presentations and/or workshops and possibly invites guest instructors.

 

Optimising/Knowledge sharing:

  • Stays informed of the developments within the own division and the other divisions.
  • Identifies possibilities to let colleagues of different divisions and disciplines cooperate in such a way that combinations of experts can be deployed at (new) assignments and at (new) clients or that lead to new services.
  • Shares information and knowledge that can be in the interest of others., expanding services and positioning in the market

 

Educational Requirements:

  • Minimum BSc, MSc/PhD preferred

 

Experience Requirements:

  • Extensive experience in leading and developing a team.
  • Extensive experience and knowledge in regulatory CMC requirements for advanced medicinal products in Europe.
  • Experience in managing and working on a wide variety of projects for different clients.
  • Experience in working together with clients and meeting their needs.

 

Necessary Skills and Abilities:

  • Proven track of strong leadership skills.
  • Knowledge and understanding of the developments in the relevant areas of attention.
  • Strong project management skills
  • Knowledge regarding developments and trends in the market.
  • Knowledge of strategic developments within the organization.
  • Knowledge of relevant national and international standards and guidelines in the pharmaceutical law and relevant guidelines.
  • Strong interpersonal skills, communication, and negotiation skills.
  • Excellent attention to detail and focus on quality.
  • Strong verbal and written communication skills in English and one other European language preferred.
  • Ability to prioritize workload and meet deadlines both for self and for team.
  • Capable of resolving conflict in a constructive manner.
  • Ability to speak effectively in interpersonal situations and presentations before groups of employees and clients.
  • Flexible and proactive toward changing needs.
  • Proficiency in MS Office systems.
  • Must be willing to travel at least 20% of working time.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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Company Overview

Berlin, Berlin, Germany

ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More

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