JJOB OVERVIEW:? Pharmaceutical Marketing Code, policies and procedures and relevant legislation (e.g. Medicines Act 101and Skills Development Act)? Policies relating to interaction with healthcare professionals and organisations? Internal SOPs related to departmental managementDUTIES AND RESPONSIBILITIES:Position Summary:The Compliance Manager will oversee two compliance aspects : regulatory compliance, especiallypromotional material and ethic compliance for a subsidiary of an international pharmaceutical company. This role involves ensuring that all aspects of the company's operations adhere to national and internationallaws, industry standards, and corporate policies, particularly those related to drug development, clinicaltrials, marketing, and distribution.Key Responsibilities:Regulatory compliance, o MCA knowledgeo Reviewing of promotional materialo Training and upskilling employees on Compliance parametersEthic compliance• Policies & processes : o Develop and implement compliance policies and procedures ensuring alignment to the companies legal framework. i.e purchasing policieso Ensure the companies adherence to compliance related policies and procedures by developing sustainable Training and guidance on said policies. o Act as support and first line of defence on all Ethics and Compliance for the business.• Data integrityo Ensure data accuracy in maintaining systems and records for audit purposeso Manage internal and external approval processeso Maintain accurate, updated paper and electronic files and records for easy retrieval andensure the two systems interface accurately• Auditso Conduct regular internal audits to ensure faithfulness to the company policies and SOP's.o Manage any external and internal audits around compliance and the management thereof o Identify compliance gaps and take corrective action to remedy theseo Manage implementation of internal audit recommendations• Trainingso Attend and complete the mandated compliance training provided by Head Quarters,o Monitor business compliance to the control frameworks, escalate issues of non-compliance and identify and follow-up on training and communication needso Provide ongoing training and guidance on relevant compliance matterso Provide ongoing education to the Sales force on market conduct best practice and risks o Follow mandatory trainings• Advisor and compliance responsibleo Become the contact person on all matters relating to Compliance. Serve as an advisor to other department on compliance related queries and questionso Stay updated with changes in legislation affecting the pharmaceutical industry.o Collaborate with global teams to align subsidiary compliance practices with overall company standards and to share knowledge and best practice and leverage resources.o Implement the compliance framework pertaining to interaction with healthcare professionals and organisationso Ensure those departments that interact with healthcare professionals and organisations understand their key risks, priorities and focus areas from a compliance perspectiveo Understand the risks relating to code compliance, internal and external regulations and display proactivity in identifying, mitigating and/or escalating risks to relevant stakeholders promptlyQualifications:- Bachelor's degree in Pharmacy, or related field.- Proven experience in regulatory compliance (promotional materials) within the pharmaceutical industry.- Strong understanding of South African and international pharmaceutical regulations.- Excellent communication and interpersonal skills.- Formal compliance qualification through CISAThe ideal candidate will be a detail-oriented professional with a proactive approach to problem-solving and a strong ethical standard. The ability to work independently as well as part of a global team is essential. Fluency in English is advantageous.• Job Training and Experience:o Minimum 3 years' experience in Compliance (Marketing material) – (must have human medicine experience and biologicals)o Knowledgeable and experience regardingo In depth knowledge of Regulations, Compliance and Marketing Code of the Pharmaceutical industryTECHNICAL SKILLS? Able to analyse, identify and remediate skills and compliance gaps? Risk assessment and remediation skills? Able to interpret and advise on the spirit and content of compliance to relevant regulationsBEHAVIOURAL SKILLS? Able to translate, execute and align strategy? Highly analytical and attentive to detail with strong big picture thinking and reasoning skills? Able to build relationships and influence at all organisational levels (internally and externally)? Able to influence, facilitate and present information in ways enable learning? Able to identify, co-ordinate and juggle priorities in line with organisational needs ? Able to use the full MS Office suite and learn and apply new system requirementsINDISPENSIBLE QUALITIES:a) Focus b) Attention to detailc) Flexibilityd) Planning and organisatione) Communicationf) Teamworkg) Confidentialityh) Agile and able to work in a fast pac
