Code of Practice Compliance Manager and ZINC lead - United Kingdom
Description Role and Responsibilities:
- Conduct regular monthly audits on promotional, non-promotional and examination materials and activities from both a quality and SOP/WP-compliance perspective (to include ZINC, FAST and hard-copy archiving records)
- Identify non-compliance, and ensure the development and implementation of appropriate corrective and preventative actions to optimize compliance with company policies and procedures
- Act as the ZINC lead for the affiliate, liaising with ZINC-MAPs and relevant internal stakeholders to optimize and enhance the use of ZINC for the UK/Ireland affiliate
- Single Point of Contact for changing access rights in ZINC
- Conduct regular ZINC training sessions: responsible for training all new users (including agency partners) on ZINC at our company implement and run a monthly ZINC clinic to assist users with ZINC issues and run training sessions as required to raise awareness of ZINC functionalities and changes following any upgrades
- Provide regular ZINC and FAST metrics on the performance of the UK/Ireland Affiliate in relation to activities/material review and approval. Inform Code of Practice Compliance Forum of trends and significant issues at each meeting
- Provide support for internal /external audits for the UK/Ireland Affiliate in relation to Code of Practice activities
- Coordinate the Code of Practice complaints process in relation to inter-company disputes, PMCPA complaints and MHRA advertising/promotional complaints, working with internal stakeholders as appropriate
- Serve as a first-line point of contact on questions from colleagues regarding company Code of Practice-related processes.
- Escalate questions where required and work with final signatories and the Code of Practice Compliance Forum (as appropriate) to ensure that timely responses are delivered
- Responsible for the development/maintenance of Code of Practice-related work practices and job aids in collaboration with the relevant internal stakeholders
- Manage the hard-copy archiving process in accordance with company written procedures
- Manage withdrawal of promotional and non-promotional items as per company written procedures
- Maintain a current list of items in use
Skills and Knowledge Requirements:
- Previous pharmaceutical industry experience is essential with significant experience and knowledge of the ABPI and IPHA Codes of Practice.
- Previous experience/knowledge and understanding of quality systems, processes, audit and inspection is desirable
- Must be pro-active, self motivated, highly flexible team player
- Excellent assertiveness, persuasion and negotiation skills
- Excellent written and verbal communication skills including strong interpersonal skills
- Ability to understand laws, codes and policies and the need to translate into practical, workable procedures and clear guidance for all involved
- Effective problem solving skills
- Excellent time management and planning / organisational skills with the ability to work to strict timelines and handle multiple priorities / deadlines without losing attention to detail
- Experienced ZINC user
- Our company is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
- Our purpose as a company is to discover and develop therapies that will change the course of human health.
- We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
- With a presence in more than 70 countries - and growing.
- We look for talented people to grow our business, advance our science and contribute to our unique culture.