Senior manager / medical writing

AmerisourceBergen; United States; Remote; USD 60,000 - 100,000; Full time

Job description

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

Role Summary:

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

Job Description:

• Preparing the technical documentation for In Vitro Diagnostic (IVD) medical devices as per the European In Vitro Diagnostic Regulations (EU IVDR), 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 IVD 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 IVD products and medical devices

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Required Skills:

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

• Knowledge on Companion diagnostics

• Expertise in EQA 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 Companies Affiliated 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 [e-mail] . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned