Medical Expert – Small Pharmaceutical Company – Work across all departments

We are recruiting for a Medical Expert / Senior Medical Director for a small pharmaceutical company specialising in low volume, difficult to manufacture pharmaceutical products. This expert will be the medical expert for the company and will work across all departments (Medical Affairs, Pharmacovigilance, Regulatory Affairs, Business Development, M&A etc.) providing medical expertise and insight. This is a fantastic opportunity for someone looking for a broad and challenging position working closely with senior leadership reporting into the Chief Operating Officer.

Responsibilities

General

• Educate, advise and train cross-functional teams on treatment pathways and prescribing decision making on relevant therapeutic areas.
• Assume the role if in-house medical expert, advising colleagues, partners, regulators and other stakeholders in the opportunities for enhanced clinical use, safety and other medical insights for the company’s products and competitors’ medicines
• Participate in the preparation and/or review of justifications for pricing adjustment applications for the Ethical Pricing Intelligence Committee (EPIC)

Departments

Pharmacovigilance

• Oversee the PV function, assuring compliance with relevant regulations and interacting with the EU QPPV to review relevant documents
• Review and medically assess, where necessary, adverse event cases
• Prepare, or review and approve, PV-related reports as part of the maintenance of core products in the portfolio
• Review and approve agreements and other documents that confer medical-related responsibilities on the company
• Maintain medical oversight of any clinical studies in which the company is the Sponsor

Medical Affairs

• Provide guidance and support, where relevant, to escalated medical enquiries especially when raised by GPs, hospital doctors and other physicians to ensure swift and accurate responses are offered

Regulatory Affairs

• Prepare, or approve, clinical expert statements where demonstrable evidence of expertise in the therapeutic area is provided
• Review Product Information (SmPCs, PILs etc.)
• Provide guidance and insights to the regulatory affairs team as a subject matter expert, relating to the maintenance of existing products and the interrogation of newly acquired products

M&A

• Subject target acquisition products to comprehensive scrutiny as part of the collective due diligence effort in M&A projects, identifying risks, strengths, opportunities and threats to the go/no go decision
• Interact with medical counterparts in divesting companies
• Work closely with M&A in the understanding of prescribing formularies, prescribing and clinical usage practices, patient behaviour and how these factors drive sales of products, formulations, pack sizes, etc.

Market Access

• Provide medical and clinical expertise in the creation of compelling Market Access justifications

Commercial

• Work closely with the Commercial team, creating a medical, clinical or safety rationale for increasing the competitive commercial prospects for the company’s products
• Act as one of the company’s approvers of promotional materials in the context of the medico-legal regulatory (MLR) process Develop and advise on brand strategies and key marketing messages in line with ABPI and other compliance guidelines
• Identify KOLs across target countries and develop strong working relationships within key therapy areas to support M&A activities and marketing strategies.

Requirements

• Medical Doctor
• Experience with ABPI or similar
• Knowledge of relevant medicinal product regulations in the UK
• Experience in the assessment of adverse events and medical information enquiries

Following your application Simon Trebilcock, a specialist Medical Recruiter with over 7 years’ experience recruiting in the scientific field will discuss the opportunity with you in detail. Eager to both give insight into the future of the opportunity and company but also learn more about your vision for your career growth. If desired Simon would look to remain in contact to alert you to opportunities which align with your interest and career plans.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Simon Trebilcock for any further information

Email -  strebilcock@planet-pharma.co.uk

Telephone - +44 (0) 203 868 1001 .

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

A note from the author – Simon Trebilcock

Don’t meet every single requirement? Studies have shown that women and people from minority groups are less likely to apply to job adverts unless they meet every single qualification. At Planet Pharma we are dedicated to building diverse, inclusive and authentic workplaces, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the advert, we encourage you to apply anyway. You may be just the right candidate for this or other roles.