Medical Affairs Manager

Accountabilities: Provide guidance and oversight on FDA, EMA, MHRA, and other health authority regulations relevant to Medical Affairs activities.

Assist with the development, review, and improvement of Medical Affairs SOPs and other procedural documents.

Participate in developing and delivering compliance-focused training using established training modules and customized content where appropriate.

Support periodic assessments of Medical Affairs GxP role-based training plans and recommend improvements to existing curricula.

Assist with audit readiness activities in preparation for regulatory agency inspections.

Support internal and external routine audits, including document reviews and related compliance activities.

Collaborate with cross-functional teams, including Clinical Operations, Business Conduct, and other functional groups, to support consistent compliance practices.

Requirements

Previous experience in a pharmaceutical Medical Affairs leadership or lead-level role is required.

Strong understanding of Medical Affairs activities and the regulatory and compliance requirements affecting pharmaceutical organizations.

Ability to interpret health authority regulations and translate requirements into practical procedures, training, and compliance guidance.

Excellent written and verbal communication skills, with the ability to work effectively with cross-functional stakeholders.

Strong organizational and planning skills, with the ability to manage multiple priorities in a regulated environment.

Excellent problem-solving and analytical abilities, with a proactive approach to identifying and addressing compliance issues.

Ability to work on a W-2 basis.

Candidates should be prepared to work on-site; hybrid work is available only for candidates who are local to the site.

This is not a fully remote position .

A Word-format resume must be submitted with the application.

Benefits

$45/hour compensation.

Contract position with a 40-hour work week .

W-2 employment arrangement.

On-site work, with limited hybrid flexibility for candidates local to the site.

Opportunity to work across multiple therapy areas and collaborate with teams such as Clinical Operations and Business Conduct.

Exposure to Medical Affairs compliance, GxP training, regulatory inspections, and audit activities.

No benefits are offered for this contract role , according to the source posting.

Candidate information is handled confidentially in accordance with applicable EEO guidelines.

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