Compliance Officer

6 months ago

Reading, United Kingdom STADA Arzneimittel AG Full time

At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.**Britannia Pharmaceuticals**, part of the STADA Arzneimittel AG group of companies, is a UK based pharmaceutical company specialising in the neurology market. Britannia focuses on innovative products for chronic and serious medical conditions, and in particular, the treatment of Parkinson’s disease. We are highly committed to improving the quality of life for People with Parkinson's disease.**Compliance Officer**
- Reading | United Kingdom (GB) | Full-time | Fix-term- To lead and support Britannia Pharmaceuticals (BPL) with regards to compliance activities including those mandated by STADA Global and with a particular focus on EFPIA, ABPI and other international regulations in the conduct of the company’s business. This role is fixed-term, for a duration of 14 months.**Key Accountabilities**
- Management of PMCPA cases and audits as applicable, ensuring all materials are collated and remedial actions completed
- Leads on Compliance forums and meetings
- Drives and embeds the Compliance Culture within the organisation
- Develops and implements the compliance strategy for the company and provide solutions for any areas of weakness
- To ensure that the understanding of all regulations governing promotional and non-promotional activities are up to date, completing the necessary training to all staff and detailed communication is given to BPL Management at all times
- Provide Compliance review and act as a Compliance Signatory for all promotional and non-promotional materials in the approval system
- Overall management/administration of the copy approval system
- Design and implement training programmes to the Company’s personnel on compliance and ensure the communication and training is up to date at all times e.g. new Code roll out and training
- Monitor and educate on updates to healthcare compliance in line with the local regulations
- Responsible for the Donations, Grants and HCP Support processes
- Provide guidance and support for commercial and medical activities including, Advisory Boards, Meetings, Conferences, market research and package deals.
- Regularly conduct risk assessments for the business and propose remediation plans
- Responsible for creating and implementing templates for KOL contracts ensuring these are in line with the ABPI code
- Management of the Transfer of Values (TOVs) database and responsible for collating and disclosing UK TOVs in line with the ABPI deadlines
- Management of Cross-Border TOVs where applicable
- Compile monthly dashboard relating to Compliance activities, material statistics and deviations
- Record all Compliance deviations and implement CAPAs/remedial actions

**Compliance**
- Is responsible for working in accordance with our compliance procedures, legislation and regulatory requirements at all times. This includes, but not limited to, directives and guidance such as PMCPA, NMC, APBI Code of Practice, GMDP and other GxPs**Person Specification (skills required to do the job)**
- A Life Science degree or equivalent. Experience in the pharmaceutical industry as a Compliance officer or other relevant experience essential
- Ability to communicate information clearly and logically, both orally and in written form is essential
- A thorough and complete working knowledge of the ABPI Code of Practice and MHRA Blue Guide
- Knowledge of FCPA and UK Bribery Act
- Ability to assimilate and interpret scientific and other relevant information
- Ability to plan and prioritise own workload essential
- Understanding of compliance systems and the regulatory environment is essential
- High standards and attention to detail
- Outstanding analytical skills - science-based and marketing oriented
- Broad scientific and medical knowledge, with continuous expansion and learning ability
- Strong Medical Communications skills (study evaluation and interpretation, medical writing, presentation development, training skills, usage of medical / scientific databases, usage of online tools etc.)
- Organisational excellence, with a relentless pursuit of quality
- Displays strong organisation and time management skills; reliable in completing tasks and delivering on commitments in a timely manner
- Builds effective relationships with a variety of external and internal customers - a cross functional leader when required
- Ability to work under own initiative - proactive problem solving approach
- Good understanding of business needs
- Ideal - previous experience of intercompany dialogue, appeal board attendance or PMCPA audit

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