Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: Medical Information Specialist
Location: Santa Monica CA 90404
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Job Overview
The Medical Information Specialist is a contract role supporting day to day Medical Information (MI) including Medical Review Committee (MRC) responsibilities. This role coordinates cross functional review activities tracks MI projects and deliverables and supports timely compliant content review and approval. The Specialist works closely with Medical Legal and Regulatory stakeholders to manage workflows support system operations and assist with inspection readiness while driving efficient and consistent MI processes.
Key Responsibilities
- Manage content submissions routing version control and approvals in Veeva
- Coordinate MRC schedules agendas meetings and reviewer follow up
- Track MRC and MI timelines; identify and escalate risks or delays
- Maintain MI trackers (content updates inquiries escalations project status)
- Collect and report MI/MRC metrics (cycle time volumes trends)
- Support MI content lifecycle (FAQs standard responses scientific content)
- Maintain MI SharePoint/team sites support portal or website updates
- Support SOPs templates training materials and workflow training
- Assist with audit and inspection readiness documentation
- Ensure compliance with SOPs quality standards and regulatory requirements
- Support MM launch readiness and post-launch MI activities
- Participate in continuous process improvement initiatives to enhance MRC and MI efficiency
- Support system testing user acceptance testing (UAT) and implementation of MI-related tools or process enhancements
Qualifications
- Bachelors or advanced degree in life sciences pharmacy healthcare project management or a related field
- 3 5 years of experience in Medical Information medical content review or pharmaceutical project management
- Hands-on experience with Veeva Vault (PromoMats MedComms or similar modules) or comparable content management systems
- Strong project management organizational and stakeholder coordination skills
Key Competencies
- Attention to detail and strong quality mindset
- Ability to manage multiple priorities in a fast-paced regulated environment
- Excellent written and verbal communication skills
- Proactive problem-solving and continuous improvement orientation
- Ability to influence and collaborate across cross-functional teams
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses prim...
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: Medical Information Specialist
Location: Santa Monica CA 90404
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Job Overview
The Medical Information Specialist is a contract role supporting day to day Medical Information (MI) including Medical Review Committee (MRC) responsibilities. This role coordinates cross functional review activities tracks MI projects and deliverables and supports timely compliant content review and approval. The Specialist works closely with Medical Legal and Regulatory stakeholders to manage workflows support system operations and assist with inspection readiness while driving efficient and consistent MI processes.
Key Responsibilities
- Manage content submissions routing version control and approvals in Veeva
- Coordinate MRC schedules agendas meetings and reviewer follow up
- Track MRC and MI timelines; identify and escalate risks or delays
- Maintain MI trackers (content updates inquiries escalations project status)
- Collect and report MI/MRC metrics (cycle time volumes trends)
- Support MI content lifecycle (FAQs standard responses scientific content)
- Maintain MI SharePoint/team sites support portal or website updates
- Support SOPs templates training materials and workflow training
- Assist with audit and inspection readiness documentation
- Ensure compliance with SOPs quality standards and regulatory requirements
- Support MM launch readiness and post-launch MI activities
- Participate in continuous process improvement initiatives to enhance MRC and MI efficiency
- Support system testing user acceptance testing (UAT) and implementation of MI-related tools or process enhancements
Qualifications
- Bachelors or advanced degree in life sciences pharmacy healthcare project management or a related field
- 3 5 years of experience in Medical Information medical content review or pharmaceutical project management
- Hands-on experience with Veeva Vault (PromoMats MedComms or similar modules) or comparable content management systems
- Strong project management organizational and stakeholder coordination skills
Key Competencies
- Attention to detail and strong quality mindset
- Ability to manage multiple priorities in a fast-paced regulated environment
- Excellent written and verbal communication skills
- Proactive problem-solving and continuous improvement orientation
- Ability to influence and collaborate across cross-functional teams
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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