Job description

Site Name: Belgium-Wavre, Italy - Siena, Poznan Grunwaldzka, UK – London – New Oxford Street

Posted Date: April 26th 2025

Job purpose: 

Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. 

Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Make recommendations for the further characterization, management, and communication of safety risks.

Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.

Your responsibilities: 

Scientific/Medical Knowledge PV Expertise

Responsible for signal detection and evaluation activities for assigned products.

Drive production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).

Author the SERM safety contribution to global regulatory submissions in partnership with the product physician.

May respond to auditors/inspectors’ requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.

Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.

Make sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identify, evaluate, and recommend solutions to problems.

Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.

Cross-functional Matrix team leadership

Support and Facilitate safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.

Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.

May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.

Build strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.

Communications (verbal, written) and Influencing (internal PV Governance and External LTs)

Present complex issues to senior staff members at the GSK Senior Governance Committees.

Demonstrate initiative and creativity in performing tasks and responsibilities. Proactively contribute ideas to improve existing operations.

Proactively contribute ideas to improve existing operations.

Participate in process improvement initiatives within GCSP and contribute to advancement of methodology and process by generating new ideas and proposals for implementation.

Possess effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listen and respond appropriately to the views and feedback of others.

Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.

Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective.

Black Pharma’s (BP) Marketing Department promotes the vision, mission and aims of the organisation. We are the face of BP, coordinating and producing all materials representing the organisation. It is our job to showcase the brand of BP to our community, customers, and prospects.  

The Marketing Lead will oversee the coordination of event campaign logistics, digital support, promotional materials, and special projects, serving as the primary point of escalation for the Social Media Assistants and Marketing Assistant. They will create and manage a detailed social media strategy to enhance visibility and drive traffic across all of BP's social platforms. Additionally, the Marketing Lead will ensure the smooth flow of information and communication, distributing it in alignment with the overarching marketing plan and strategy.  

Areas of responsibility
Collaboration and Ideation:  
• Collaborate with team members to brainstorm and create innovative marketing content.  
• Develop marketing strategies for social media platforms, member and partner engagement.   

Content creation and Community Engagement:  
• Create and manage content for newsletters, social media, and other communication channels.  
• Oversee all of BP’s social media channels ensuring a timely response to all enquiries and develop new content in conjunction with the wider Marketing Team.

• Execute social media campaigns to build followers, enhance visibility, and drive engagement.  

Communication and Branding:  
• Oversee communication strategies and ensure consistent branding across all channels.  
• Build an archive of photography and video content to build the BP brand keeping it relevant and up to date. 

Content Review and Consistency:  
• Review documents and presentation decks to ensure consistency with branding guidelines.

• Liaise across departments to address marketing needs and ensure cohesive messaging across the organisation.  
• Optimise content for search engines and provide ongoing analysis and performance reporting  

Partner Liaison:  
• Coordinate with partners to obtain approvals on marketing materials.  
• Develop merchandise, branded digital banners, event materials in collaboration with other team members.

Job description

Site Name: UK - Hertfordshire - Stevenage

Posted Date: Mar 21 2025

Scientific Director of Respiratory Biology in the Respiratory, Immunology and Inflammation Research Unit (RIIRU)

Job purpose:

Reporting to and working closely with the Head of Respiratory Biology, the Scientific Director of Respiratory Biology will be a key individual in building a next generation respiratory strategy for COPD, IPF and related lung diseases and to support continued progression and expansion of the existing respiratory clinical portfolio. The successful candidate will work with their respiratory biology team, RIIRU clinical and translational partners, and the larger GSK matrix for internal research and external academic collaborations to deliver new targets and candidate drugs for respiratory diseases. In addition, the Scientific Director will work closely with Business Development to identify external asset opportunities, perform due diligence, and present recommendations to GSK governance. Importantly, the candidate must be a recognized subject matter expert in either COPD or IPF and have a deep understanding of mechanisms driving disease progression as well as robust knowledge of complex human model systems and translational research.

Key Responsibilities:

Lead and mentor a team of drug discovery scientists supporting target ID, pre-clinical and clinical projects.

Scientific Leadership

contribute to the development of the strategic plan for the next generation of targets in COPD and IPF

support the continued development, life cycle innovation, and combinations of the existing clinical portfolio

monitor research and market trends, competitive landscape, and customer insights to identify opportunities and risks, and develop appropriate strategies to maximize market share and revenue.

support the management of a Scientific Advisory Board to foster a network of external experts and key opinion leaders to build an innovative, next generation portfolio and advance the existing clinical portfolio. 

Build cross-functional collaborations to perform efficient target selection and progression and support the existing clinical portfolio with key internal partners including other lines within RIIRU (clinical and translational teams), Research Technology, Precision Medicine, quantitative science teams and others.

Establish and maintain external partnerships including collaborations with academic institutions, contract research organizations (CROs), and other external partners to access cutting-edge technologies, complex model systems, bio-samples, and research capabilities.

Identify/support Business Development for the evaluation and diligence of external opportunities to complement the GSK respiratory portfolio.

Drive compliance and quality in the discovery of innovative respiratory assets in priority respiratory diseases and mechanisms, ensuring compliance with relevant policies and adhering to quality standards. 

Major Tasks

• To plan/ schedule and perform on site service support as required which includes installation, preventive maintenance and repair of all Bayer injection systems at customer sites in a defined territory.  This is a field-based role requiring travelling in own and adjacent territories, including overnights as required

• To carry out electrical safety and pressure safety testing on Bayer injection systems

• To work with clinical and site services staff and scanner manufacturers on the planning, installation and testing of Bayer injection systems in hospital, mobile and armed forces clinical sites

• To follow electrical/mechanical and installation guides for maintaining, troubleshooting, repairing and installing Bayer injection systems in hospital, mobile and armed forces clinical sites

• To manage in-field software and mechanical updates to a clinical portfolio of Bayer injection systems

• To contribute to the national service revenue objective (~£5m annually), by generating revenue from service activities and maintenance contracts

• To be responsible for the control and maintenance of own service inventory and tools

• To accurately complete and submit in a timely manner all required administrative paperwork associated with job responsibilities, including maintenance and update of customers’ details and equipment locations on company database

• To follow and adhere to all service department/company processes and procedures as outlined and required

• To provide, where necessary, technical phone and E-mail support for customers and dealers within service region

• To be an active member of both the Service and Regional teams

This role is focused on proficiency in strategy & problem solving, shaping the licensing pathway for UK regulatory approval.   To be successful in this role we are looking for an experienced and individual contributor, who can successfully operate with minimal supervision.

The role will lead the UK licensing process for assigned Marketed Authorisations (Mas) from early pipeline development, utilising new opportunities offered by MHRA for support of highly innovative products. They also act as a mentor for less experienced Regulatory Affairs Managers (UK or EU).

The Post Brexit UK regulatory system is evolving rapidly and becoming more complex, regulatory strategy is critical to the success of future licences.

The Bayer portfolio is broad, from established products of 20+ years to cell and gene therapies in development, medical devices and combination products and the role of digital to expedite development pathways and improve patient experiences. This is all underpinned by complex regulatory requirements and strategies to ensure Bayer assets meet the fundamentals to successful commercialisation – the Quality, Safety and Efficacy of our assets

The role includes:

• Management of several MAs to ensure the input of regulatory expertise into decision making of brand teams plus local and global RA management. Identify potential regulatory risks to operational plans and propose options to mitigate risks.

• Lead above country licensing pathway as an ACCESS RAM. ACCESS collaboration drives five stringent regulatory authorities (UK, Australia, Singapore, Switzerland, Canada) to align on regulatory policy and licensing decisions to facilitate access to patients through collaboration and work-sharing. The ACCESS RAM performs the co-ordination role as required across the participating Bayer affiliates and global teams

• Promoting and fostering close relationships within Pharma UK, Global Regulatory and Health Authorities to ensure Pharma needs and priorities are met and to advise and agree on regulatory strategy and data requirements.

• Critically evaluating submission packages in line with regulatory requirements to eliminate deficiencies prior to construction and submission of MA applications withing agreed timeframes.

• Preparing high quality, licence applications to gain approval for clinical trials and the marketing of products, and to maintain existing licences and product information according to statutory requirements. Ensuring applications meet UK national, EU and internal compliance requirements.

• Monitoring and influencing the assessment process to expedite and optimise the outcome of their submissions. Driving negotiations with MHRA to ensure best possible outcome which may include, for example, optimal product labelling or assurance of supply continuity and delivery of their commitments and deadlines.

• Contributing to continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.

• Representing UK Regulatory in the New Asset Evaluation Team (NAE) as one of the must win countries for new asset development.

• Act as RA Lead (UK LRAM) in the Global Regulatory Team (GRT) and act as a mentor & role model to other members of the UKI RA team & EU RAMs. Proactively contribute to and engage with internal and external networks.

• Advise local teams and regional/international colleagues on regulatory topics, intelligence & policy and submission strategies, presenting available options and making recommendations.

Key Tasks

• Strategic regulatory leadership of assigned products.

• Actively contributing on UKRA input into global meetings (pipeline development), with regards to current and future regulatory changes and making proposals to Head RA UKI on product regulatory strategies.

• Acting as RA Lead for the management, preparation and submission of new MAAs, ILAP Innovation Passports (IP) / Target Development Profiles (TDP), UK PIPs and other local submissions as assigned. Leading Health Authority meetings for local activities such as pre-submission meetings, HA pipeline meetings, HA clarification meetings, UKI Policy topics.

• Assuming the role of NAE member for specific products / therapy areas representing UK Regulatory as one of the must win countries for new asset development support. This includes providing information on the Regulatory environment, shaping early development decisions and providing aligned input for strategic development decisions.

• Providing regulatory advice and support for divestment and in-licensing opportunities.

• Independently managing new MA submissions, e.g. Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness.

• Proactively liaising with MHRA and global regulatory and ensuring prompt professional responses to questions are provided to meet the earliest possible approval timeframe.

• Preparing, co-ordinating and submitting high quality, MA applications, life cycle management activities, CTA applications and modifications, according to national/EU requirements (including renewals, variations, expert statements). Maintaining medicine dossiers and medical device technical files within agreed portfolio to statutory requirements.

• Being accountable for the content of local label documentations released to prescribers and patients, ensuring the quality of documentation is optimised and that potential regulatory hurdles to successful UK launch are identified, minimised and documented. Checking incoming documentation from global RA colleagues to ensure MAs and CTAs comply with HA guidance (e.g. HMRs and UK CTR).

• Submitting and maintaining official local medicines information, including SmPCs, Patient Information Leaflets, packaging texts, RMPs and any associated Educational Material.

• Creating, compiling and submitting applications to any other authorities (e.g. HSE or EPA gene therapy trials) as required.

• Providing information on regulatory procedures, competitors, guidelines and policy to effectively advise Head of RA UKI, global regulatory and the brand teams / therapy areas. Keeping Head RA UKI fully informed on key project-related topics.

• Partnering with local and global teams to provide regulatory strategic and technical expertise for submissions, HA interaction and brand strategy.

• Understanding and proactively communicating with internal stakeholders about the impact of regulatory information and intelligence relevant to the Pharma business. Promoting awareness of regulatory requirements within brand teams and with other key stakeholders. Developing positive relationships with key stakeholders and proactively identifying opportunities to add value to customers. Effective communication with UK cross functional team members to ensure UK strategy is clear.

• Ensuring communication of any regulatory changes to the business as necessary to support licence compliance with prompt circulation of approved documents to appropriate personnel and efficient maintenance of Regulatory files and databases.

• Working closely and swiftly with cross functional teams to address critical issues, e.g. batch recall or other batch release issues.

• Leading the adoption and implementation of new systems and processes to streamline routine regulatory activities. Being an ambassador for UK RA by managing key regulatory challenges and pro-actively highlighting potential impact of external changes on internal processes.

• Participating in Quality System Document (QSD) review process and updating QSDs related to principal accountabilities as required.

• Ensuring an on-going commitment to self-education, professional development and training (Continuing Professional Development (CPD)).