Medical Affairs Manager in New York at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Medical Affairs Manager based in United States.
This role provides compliance-focused guidance and oversight within a pharmaceutical Medical Affairs organization.
You will help interpret and apply health authority requirements across regulated activities.
The position supports the development and maintenance of SOPs and procedural documentation.
You will contribute to compliance training and help strengthen role-based GxP training programs.
The role also supports audit readiness and participation in internal and external audit activities.
You will collaborate with cross-functional teams across areas such as Clinical Operations and Business Conduct.
This is a contract opportunity offering hands-on exposure to a regulated pharmaceutical environment.
- 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.
- 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.
- $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.