Medical Affairs Review and Approval Expert (MARA) – iAgora Europa – null

Descripción del puesto:Breakthroughs that change patients’ lives… At (COMPANY NAME) we are a patient centric company, guided by our four values: Courage, Joy, Equity and Excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.At (COMPANY NAME) we know that great things happen anywhere people come together with one shared goal.We are recruiting for a new exiting role and hope to catch your interest to join us as Medical Affairs Review and Approval Expert (MARA). This is a role that we have elaborated from our current role title Medical & Promotional Compliance Officer to further strengthen our Medical Affairs Team, and we are happy to meet with candidates eager to bring new perspectives.HOW WE IMPACT PATIENTSWe contribute to transforming the lives of patients through science. We lead the medical conversation partnering broadly to generate scientific evidence. In this role your will be at the heart of science focused on our breakthroughs that transform patients´ lives.HOW YOU WILL CONTRIBUTEThe PCO/Medical Affairs Review and Approval Expert (MARA) is the Medical expert responsible for the medical review and approval of promotional and non-promotional materials as well as regulatory texts across BUs.THE KEY RESPONSIBILITIES IN THIS ROLE INCLUDE: * Review and/or approval of promotional and non-promotional materials with medical content as well as regulatory texts and translations across BUs and in compliance with local law and regulations and global and local procedures through the relevant systems (MLR review and approval in GCMA, including sign-off as Final Country Signatory) * Ensure scientific accuracy of claims, references and translations and alignment with local product label * Being a key contributor to ensure local content promotional compliance * Collaborates closely with the relevant cross-functional colleagues across BUs, to ensure a reliable and streamlined approach for content generation * Partners with relevant colleagues to proactively contribute to innovative content practices * Cooperate closely with Medical Quality Governance team on quality reviews and internal and external audits * During revision and approval of promotional materials identify risks, and if possible proactively suggest solutions for rendering the material approvable or discuss and evaluate risks with Country Medical Director, Corporate Compliance Lead, local Medical Quality Oversight Manager (MQOM), and/or BU Medical Lead of Country Manager, as appropriate * Participate and captain actively in training on promotional material requirements (Global and Local requirement) and on Promo tool System for relevant colleagues.WHAT WE EXPECT * Medically qualified background as MD, Pharmacist, MSc or other relevant University degree; e.g. candidate is medically qualified. * Ability to interpret scientific publication and scientific data * Experience in MLR review / Experience from working in the Pharmaceutical industry. * Up to date knowledge of the relevant and applicable Codes of Practice and regulations * Fluency in Danish and English. * In depth knowledge of relevant rules, codes and legislation, e.g. National legislation, Act on Advertisement, ENLI and EFPIA codesWe will appreciate a candidate with a proactive problem solving mindset, strong ability to listen and understand the internal and external stakeholders, as well as project management skills. You do enjoy and contribute in team work and x-functional collaboration. To thrive in this role great communication skills and attention to detail for eloquent wording in presentations and company material is an advantage as well as experience working in global IT systems.WHAT YOU CAN EXPECTAt (COMPANY NAME), we invest in creating an environment which unleashes the power of our people. Some of our key drivers:Diversity, Equity and Inclusion – Everyone has something to offer. We believe that a diverse and inclusive organization is crucial to building a successful organization. (COMPANY NAME) is committed to celebrating this in all its forms ensuring we are as diverse as the patients and communities we serve.When you grow, We Grow! – All colleagues are empowered to unleash their full potential, delivering on our company purpose through non-linear career paths, made of a diverse set of experiences.Health & Wellbeing- We empower our colleagues to better care for themselves and make new investments to help them manage their mental and physical well-being. Ensuring an environment where colleagues can unleash their power and bring joy at work is one of our focus areas.ABOUT US(COMPANY NAME) Denmark has a total of ~120 employees working across different functions. Globally, (COMPANY NAME) is among the largest pharmaceutical companies with around 80.000 employees. We work within the following therapeutic areas of Internal Medicine; Oncology; Inflammation & Immunology; Rare Disease; Vaccines and Hospital products – organized in 6 corresponding business units. You will join a team of 6 experienced colleagues covering Medical Affairs and Medical Quality Compliance, who look forward to welcoming and working together with you.Furthermore, the entire medical team in (COMPANY NAME) Denmark comprise ~14 medical affairs colleagues, working within each of the 6 business units, covering (COMPANY NAME)’s wide portfolio of prioritized and pipeline products. We want to be the best at what we do and bring focus to the value of our science. Thus, the medical affairs team has a central role in the (COMPANY NAME) organization, and we collaborate with people from across the organization – in Denmark and globally – every day. We prioritize developing our skills and our networks by participating in internal and external educational and scientific activities; e.g. congresses and meetings, and we regularly publish our studies in peer-reviewed journals and contribute to global data generation.OUR OFFER We offer the opportunity to work to ensure that Danish patients have access to our medicines while further developing your skills in a job with plenty of responsibility and challenges. We promise that you will join a team of colleagues who will be eager to help you succeed and make you feel welcome with (COMPANY NAME). Furthermore, we offer: * Competitive salary, benefits and bonus program * Flexibility in the workplace; working from office, home and abroad * Open, light office space with room for interaction as well as focus * Pension and health insurance * Social gatherings and get-togethers * Gym, running and other sports events NEXT STEPFor questions related to this job post please contact Medical Director, Anne Bloch Thomsen, on phone +xx xxxxxxx2 or e-mail Axxxxxxxx.xxxxxxx@xxxxxx.xxm Job post closing date is June 14th 2022.#LI-PFEWork Location Assignment: Flexible(COMPANY NAME) is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control#LI-PFE

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