Manager, Clinical Services (Global Medical Writing)

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.

We have an exciting opportunity for a Manager of Clinical Services within Medical Writing to join us. This will be a cross-functional role involving:

• To author review and independently manage high-quality clinical documents: Clinical Study Reports (CSR) including narratives Protocol and Informed Consent Form (ICF) Investigator Brochure.
• Review and Preparation of regulatory documents as per country-specific regulatory requirements. Clinical Trial Documents (CTD) Modules (2.4 2.5 2.6 2.7)
• Excellent skillset in literature search understanding of PICOS criteria and PRISMA statement

.

• Contribute to the planning of data analyses and presentations to be used in CSRs; Ensure compliance with documentation
• Excellent data interpretation skills.
• Understanding of ICH-E6 and E3 guideline.
• Understanding of other ICH and regulatory guideline required for drug development.
• Understanding of template for Protocol as per ICH-E6 and Transcelerate Common trial protocol
• Basic understanding of statistics
  

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.

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