Regulatory Affairs Compliance & MSL support Associate

This position represents a unique opportunity to take on a role that combines expertise in medical affairs and regulatory affairs, ensuring professional development that will make the profile truly stand out in the market.

This position is a remote role focused on developing and maintaining peer-to-peer relationships with key medical experts. The person will collaborate with physicians and other medical experts to support trial enrollment, provide program protocol training guidelines and best practices and ensure that health care professionals have the most up to date information as the clinical development programs mature.

Moreover, this role involves monitoring regulatory processes to ensure compliance with legal and ethical standards, managing information flow, and conducting risk assessments. It also includes staff training on compliance updates and acting as a liaison between departments and senior management.

Key Responsibilities Include

• Develop and maintain peer-to-peer collaborations and relationships with key medical experts;
• Support clinical development initiatives including site identification, trial recruitment, registry, and presentation of final approved data;
• Collaborate with physicians on medical affairs initiatives including publications, advisory boards, medical education opportunities, training, and speaker development;
• Serve as scientific peer-to-peer resource to external disease experts and internal stakeholders;
• Support the medical community with up-to-date medical information, robust disease expertise, and product information;
• Gather new clinical insights on new data and communicate to the company Medical Affairs;
• Train internal stakeholders on key scientific and medical topics in relevant therapeutic area;
• Develop an understanding of the regional landscape including specialties involved in care of patients;
• Maintain effective and appropriate communication among internal stakeholders while maintaining full compliance with relevant requirements;
• Generate projects to provide needs based, value-added support of the medical and scientific ·community in-line with company goals;
• Uses systems to strategically map, identify, profile and prioritize thought leaders in line with the medical plan and goals;
• Maintain accurate reporting and documentation of MSL activities;
• Monitoring all operational processes and procedures to ensure that the company complies with all legal regulations and ethical standards;
• Manage information flow by researching, recording and analyzing data and information;
• Ensure that the business runs smoothly with a regular flow of information and conducting compliance risk assessments;
• Train and educate staff so that they are informed of any legal changes and updates to compliance guidelines;
• Act as a contact person and liaison between department heads, ODV and senior management;
• ·Conduct regular assessments and audits to determine whether policies are compliant with the law;

Education, Registration & Certification:

• Bachelor’s degree in chemistry, biology, pharmacy, or other medical related discipline.
• Advanced degree preferred.

Experience:

• Previous experience in Medical Affairs or Medical Science role or in Regulatory Affairs within pharmaceutical company;
• Candidate must have an understanding of compliance considerations and demonstrate ability to work compliantly in a field-based role, within the medical organization, as well as across the commercial organization;

Skills, Knowledge & Abilities:

• Advanced knowledge of English (C1)
• Excellent oral and written communication skills
• Energetically embraces responsibilities, demonstrates ability to achieve goals
• Has strong initiative, and functions well as part of a cross-functional team
• Exhibits excellent time management
• Demonstrated ability to work independently
• Experience in a start-up environment preferred
• Must be pro-active team player, flexible, and ability to work in ambiguous situations

Other:

• Field based / Home based
• Travel within region up to 50%

L’annuncio è rivolto ad ambo i sessi (D.lgs n. 198/2006) e nel rispetto di quanto disposto dall’art. 10 del D.Lgs n. 276/2003. I candidati sono invitati a leggere l’informativa privacy https://www.wexecutive.eu/privacy-policy ai sensi dell'art. 13 e art. 14 del Regolamento UE 2016/679 sulla protezione dei dati. Aut. Min. Prot. R.0000155 del 31/12/2021.