Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Medical Affairs Safety Physician Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
- Provides medical expertise, support, and clarification of science as needed.
- Participates in literature search as needed and interpretation of clinical study data in cooperation with Regional and Global Medical Affairs and Clinical R&D
- Identifies and addresses potential medical issues and ensures the implementation of risk-management strategies.
- Participates in the development of medical strategies for the medical devices assigned to him/her in the sponsor's portfolio.
- Provides medical knowledge and support to commercial, marketing, and sales teams.
- Develops and reviews medical content for congresses, symposia, and advisory boards.
- Develops and reviews and assists in the revision of strategically targeted information in response to published scientific literature, news media releases, marketing initiatives, product recalls or new or highly publicized medical discoveries or information.
- Develops and reviews medical training materials and programs that are used to support initial and continuing training for new employees.
- Develops and reviews the standard language for product information reference manuals including Frequently Asked Questions (FAQs) for new product launches, media issues, and publications.
- Provides medical support in the review of printed packaging components, labelling, and compendia.
- Participates in cross-functional teams as a medical resource for marketed products and new marketed concepts for promotional and non-promotional pieces to ensure medical/scientific accuracy.
- Assists in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS.
- Effectively organize and delegate work where applicable to complete the assigned tasks to meet deadlines.
- Mentor and bestow domain knowledge to the team.
- Ensure the assigned tasks are delivered 100% on time or before, as per project SLA.
- Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work.
- Be able to independently perform tasks with minimal guidance & supervision.
- Functionally review the team’s work for accuracy and compliance where applicable
- Ensure proper planning of the deliverable and foresee any risks that are likely to arise.
- Ensure error free and 100% quality in assigned deliverables.
- Ensure that all assigned goals [e.g. utilization and efficiency] are met as per set standards for the performance year.
- Responsible for ensuring training compliance and timesheet compliance.
- Conduct functional training for the team members.
- Support in the functional capability development of junior members.
- Follow and comply with the Company’s Code of Conduct, Policies, and Procedures
- Responsible for confidentiality, integrity, availability, and safeguarding of data.
- Responsible for reporting of security incidents and PIMS breaches as applicable
- Comply with company QMS, ISMA, and PIMS requirements and applicable regulatory requirements.
- Demonstrate adherence and compliance to PIMS/GDPR requirements as follows: processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner.
Education and Experience:
- Bachelor’s degree in science or above and in alignment with project / business team requirements
- Minimum of 5 to 7 years of relevant experience in identified functional domain/ business workstream.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words: Medical Affairs, safety physician, Medical Devices, Consultant, CRO
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