Manager, Clinical Services

1 day ago

India AmerisourceBergen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today

Job Details

  • The role is an individual contribution

  • Preparing the technical documentation for In vitro diagnostics and medical devices as per the country specific regulatory requirement.

  • 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 the IVDs.

  • Preparation of checklist for standard assessment for the legacy devices to update 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 IVD products and medical devices.

.

Experience:

  • Minimum 5-10 years

  • Target Market: Europe and US

Required Skills:

  • Strong IVD background, preferable from clinical affairs of an IVD company, or TD reviewer from a NB

  • Knowledge on Companion diagnostics

  • Expertise in EQA schemes (at least one person to join the team shall have this expertise)

  • 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 Companies
Affiliated Companies: PharmaLex India Private Limited 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 or email **** We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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