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Global Regulatory Affairs Director, Paediatrics
Permanent / Dublin, Republic of Ireland
Job title: Global Regulatory Affairs Director, Paediatrics A well-known pharmaceutical company are seeking a Global Regulatory Affairs Director to work in their recently launched paediatric centre of excellent office in Dublin. This is an exciting opportunity to join HIV and Emerging Viruses Regulatory Affairs where you will provide global regulatory strategic and technical leadership of regulatory activities for pediatric product development. Responsibilities: Responsible for providing strategic regulatory guidance on the development of global pediatric submissions, including those required in the US and EU. Responsible for leading all pediatric-related regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance for pediatric products is met for assigned product(s) and territories. Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new pediatric regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management. Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs. Requirements: Significant level of experience in Regulatory Affairs or other relevant industry experience with advanced degree Must have extensive knowledge of pediatric regulatory requirements, including ICH requirements and regional requirements for assigned territories and an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business. Degree in a scientific field is preferred Pediatric drug development experience is required Is recognized as an expert resource for Regulatory Advice in other departments. Salary and benefits: A highly competitive annual salary, car allowance, bonus, initial stock reward, annual stock reward, private medical and pension are on offer. A generous relocation package is also available - offering temporary accommodation, home sale assistance and rent contribution. To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
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UK Senior Medical Science Liaison - Rare Diseases
Permanent / England
UK Senior Medical Science Liaison - Rare Diseases A newly created position with a growing biotechnology business looking to bring products to market in the rare respiratory disease space. This organization is established in the US and now looks to expand its presence in Europe, which includes building a team in the UK. This organization has an important product launch expected in early 2021. Reporting to the UK Medical Director, your responsibilities would include: External stakeholder engagement in the field and scientific exchange, including meeting with senior KOLs / HCPs to understand their needs and best support the right outcomes for the patient population Implement and manage relevant educational meetings, expert panels, workshops, and advisory boards Contributing to and execution of the UK country medical affairs plan Supporting Clinical Operations teams to engage expert centres in clinical trial participation Champion a compliant and ethical approach to external stakeholder engagement and medical affairs strategy, collaborating constructively with commercial colleagues Support the wider team and Medical Director in additional ad hoc medical affairs plans as required Candidates requirements include: Degree qualified to at least BSc level (MSc / PhD / MPharm preferred) Significant experience as a Medical Science Liaison (MSL) in the UK pharmaceutical industry Experience in rare diseases or respiratory medicine Product launch experience, ideally whilst working within a small pharma/biotech company Demonstrable experience engaging with senior external stakeholders in field-based medical affairs both locally and nationally Someone who is capable and confident working in a small yet growing operation, where your duties can cover real a breadth of medical affairs responsibility To apply for this position please use the "Easy Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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Medical Advisor
Permanent / Berkshire, England
Medical Advisor Pharma-Partners are currently collaborating with a specialist pharmaceutical company to hire a Medical Advisor. With a strong, diverse portfolio in specialty medicine this is a great opportunity for an established medical/scientific affairs professional to join the business at a pivotal growth stage. Key Responsibilities Represent the affiliate's medical/scientific voice of expertise for assigned product(s) and relevant therapeutic areas. Provide medical / scientific expert advice / guidance to key customers for assigned products and relevant therapeutic areas, including scientific exchange and professional relationship development with key thought leaders / external experts. Provide medical / scientific input into Medical Affairs strategies for the affiliate medical department and commercial plans, as required, and medical / scientific support for medical department activities under the overall direction of the Affiliate Medical Director Provide medical affairs support to cross-functional affiliate teams Ensure that the medical affairs role is fully integrated to support the strategy and execution of affiliate business, while being functionally independent. Candidate Requirements: Medical Degree or Pharmacy degree Previous experience of working in a medical affairs role is essential. ABPI final signatory Experience with diverse therapeutic areas would be an advantage Excellent written and spoken communication and presentation skills. Salary and Remuneration: This role is offering a competitive remuneration package. To apply for this position please use the "Easy Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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Medical Advisor - Copy Approval
Permanent / Berkshire, England
Medical Advisor - Copy Approval (Final Signatory Required) Pharma-Partners are currently partnering with a leading biopharmaceutical company to hire two final medical signatories to support the delivery of compliant promotional and non-promotional materials within their haematology/oncology and speciality medicine divisions. With a strong, diverse pipeline and several key launches anticipated over the coming years this is a great time to join a growing business and have the opportunity to develop internally. Key Responsibilities Provide brand support for the preparation and final signatory approval of promotional and non-promotional material and activities. Support the continued implementation of a Code Compliant system for all promotional and non-promotional activities, ensuring the company is in line with ABPI standards, the MHRA blue guide for advertising and promotion and all applicable international Codes of Practice (EFPIA, IFPMA, and respective National Codes and National Regulatory Bodies) at all times. Provision of workable compliant solutions to support business development opportunities/product launches and contribute to the development of marketing campaigns Timely, accurate review and approval of materials in accordance with the relevant Codes of Practice. Provide Guidance to overseas affiliates and UK Affiliate as and when required Actively participate in cross-functional medical review projects to build medical review standard practices and solutions for the business Candidate Requirements: MD/MPharm that has experience as an ABPI final signatory is essential Experience working in a pharmaceutical industry across a range of therapeutic areas Attention to detail, used to working in a face paced environment and is a strong communicator Salary and Remuneration: This role is offering a competitive remuneration package. To apply for this position please use the "Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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Director, Clinical Development - Vaccines
Permanent / Boston, Massachusetts
Director, Clinical Development - Vaccines US Based Pharma-Partners are working exclusively with a world leading, specialist pharmaceutical company looking to hire an experienced leader within clinical development. As Director for Global Clinical Development you will have responsibility for strategic clinical development planning for early phase assets; ensuring collaboration with key internal stakeholders to deliver successful license applications and product life cycle management aligned with Commercial Operations strategies and the regulatory environment. Key Responsibilities: Provide strategic medical leadership and guidance to the global clinical development activities supporting new registrations and life cycle management of therapeutic compounds Ensure that the overall scientific and medical content of all clinical programs is sound, is supported by high value data driven decision-strategies and is documented through program specific Clinical Development Plans. Anticipate and address future potential clinical development needs and opportunities, based on the clinical character of the compound, evolution of the regulatory and commercial competitive environment. Ensure clinical development planning and strategies are updated for stage gate evaluations and present, as required, clinical development strategies and overall benefit:risk evaluations, pertaining to the assigned therapeutic area, to senior review committees such as Global Clinical Safety Committee, Project Review Committee, and Portfolio Planning & Prioritization meetings Candidate Requirements: Medical Doctor, Board Certification or clinical experience in Infectious Disease's/Vaccines would be advantageous Several years in global clinical development within the pharmaceutical /biotech environment, with a number of those being in key leadership positions. Ideally having worked on Early Phase clinical trials focussing on Vaccines Proven track record in liaising with global regulatory bodies and successfully delivering license applications Excellent communication and influencing skills Proven effective leadership Salary & Remuneration: Highly competitive basic annual salary plus a benefits package to include car allowance, bonus, and long term incentives/shares To apply for this position please use the "Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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