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Job Details

About Pharmalex

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

Role Summary: Assist the project leads in the CMC (Chemistry, Manufacturing, and Controls) Services Practice Area in operational tasks and all aspects of technical delivery and project management.

Responsibilities

• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC (Chemistry, Manufacturing, and Controls) aspects.
• Support with preparation, review and compilation of CMC (Chemistry, Manufacturing, and Controls) documents within the framework of regulatory affairs projects.
• Communicate with clients and Health Authorities in close cooperation with the respective lead.
• Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
• General guidance (consultancy) of colleagues and clients regarding CMC (Chemistry, Manufacturing, and Controls) Services.
• Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
• Support with VDC (Virtual Design and Construction) strategy implementation and optimization.
• Comply with and support the maintenance of internal procedures.
• Support with VDC (Virtual Design and Construction) led commercial, marketing and business development activities including proposal input and invoicing queries in close cooperation with the respective lead.
• Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.
• In agreement with Head of VDC(Virtual Design and Construction) Regulatory providing on-site regulatory support to GCS (Global Scientific Communications) clients.
• The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC (Virtual Design and Construction) Regulatory.
  
  

Education

• University degree in Life Science
  
  

Work Experience

• Basic experience in area of responsibility or demonstrable capability from a similar field; ability to acquire knowledge "on-the-job".
  
  

Knowledge And Skills

• Ability to work according to project plan and escalate potential issues according to agreed communication plan.
• Structured way of working; limited latitude within established set of procedures, may determine priorities with general supervision.
• Resolves routine (and some non-routine) problems in a thorough and timely manner. Attention to detail. High service orientation.
• Ability to prioritize and manage own time and tasks.
• Ability to convey a positive message about GCS.
• Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise. Confident appearance.
• English and Spanish business fluent .
  
  

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies: PharmaLex Spain S.L.U.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned