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Job Details

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:

Role will require writing technical documentation (Literature Reviews, Clinical Performance Reports, External Quality Assessment Analysis Reports) in accordance with the requirements of the European In Vitro Diagnostics Regulations. Candidates would have a strong background in medical writing, with specific experience with immuno histochemistry and cancer diagnostics preferred.

Job Description:

Preparing the technical documentation for In Vitro Diagnostic medical devices as per the European In Vitro Diagnostic Regulations and other country specific regulatory requirements

Drafting performance evaluation plan, report, analytical performance reports, clinical performance reports and scientific validity reports

Preparation of declaration of conformity, summary of safety and performance report for Vitro Diagnostic devices

Preparation of checklist for standard assessment of legacy devices to identify required updates as per regulations

Preparation of labelling documents as per country specific requirements

Perform and review systematic literature search for medical scientific documents and related reports

Review documents related to technical specifications, product design, performance reports related to Vitro Diagnostic products and medical devices

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Required Skills:

Strong Vitro Diagnostic background, preferable from clinical affairs of an Vitro Diagnostic company, or Technical Documentation reviewer from a European Notified Body

Knowledge on Companion diagnostics

Expertise in External Quality Assessment schemes and analysis of reports

Experience in immuno histochemistry

Experienced in clinical/medical writing (especially on performance evaluations, clinical performance reports)

Expertise in statistics

Expertise in specific therapy areas such as cancer diagnostics

Experience managing in-house and/or external clinical studies

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 CompaniesAffiliated Companies: DRA Consulting Oy

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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned