Senior Regulatory Writer

Job Title: Senior Medical Writer

 Team Leader / Director DESCRIPTION The Senior Medical Writer will be fully responsible for the creation, authoring, and management of documentation for global regulatory submissions according to appropriate regulations, standards, guidelines (ICH and GXP), and company/client requirements RESPONSIBILITIES Expert • Create and update regulatory documentation for submission to regulatory authorities according to appropriate regulations, standards, guidelines (ICH and GXP), and company/client requirements, keeping to agreed timelines • Provide support to Regulatory Consultants authoring regulatory documents • Collaborate with interdisciplinary teams, international client functions, vendors, publishing, and Regulatory Consultants • The ability to think logically and understand complex ideas and data • Ensure consistency, completeness, and adherence to agency guidelines, internal/client work instructions and SOPs throughout regulatory documentation • Prioritise multiple tasks in a fast-paced environment while keeping within agreed timelines • Stay current with industry practices, regulatory requirements, and medical developments that affect regulatory medical writing Competent • Develop Medical Writing plans and timelines to meet project and client goals • Evaluate, contribute to and review SOPs, guidelines, and work instructions to ensure regulatory documentation are standardised and adhere to relevant guidelines • Conduct literature searches to support Regulatory Applications • Take responsibility for company activities, eg, companywide training on medical writing as appropriate • Operate as subject matter expert in Medical Writing with responsibility for training and mentoring colleagues as appropriate • Provide support for business development activities. Generate business from new clients and foster relationships with existing clients Developing • Lead Medical Writing specific projects, taking responsibility for keeping to the contract, correct administration (eg, invoicing), and all related project management LEADERSHIP Expert • Keeping people focused on goals and objectives • Embodying the ethos of DLRC and communicating the strategy and values • Promoting a positive working environment Competent • Ability to lead a Medical Writing team, eg, as the lead writer for a document set COACHING AND MENTORING Expert • Sharing technical knowledge and soft skills with others • Being a role model Competent • Giving constructive feedback • Spotting and nurturing potential BUSINESS ACUMEN Expert • Understanding our consultancy business model and contributing to the business development process when required • Develop and maintain relationships with clients to sustain/grow the business • Actively promoting the company through positive actions, deeds, and words • Discovering and understanding client needs thereby delivering a tailored service Competent • Actively generating business from new and existing clients PROJECT MANAGEMENT Expert • Provide strategic input, set appropriate milestones, and monitor progress towards results • Taking responsibility for the completion of tasks/documents within a project • Identifying and resolving issues proactively Competent • Prioritising and implementing strategies to align to the client business need • Managing resource effectively TECHNICAL COMPETENCE Expert • Excellent attention to detail; able to work accurately with large data sets • Full proficiency in Word, Excel, PowerPoint, email, and the internet • Excellent written communication skills, including extensive knowledge of English grammar • Established understanding of the regulatory environment, including thorough knowledge of ICH, GXP, global regulatory pathways, and global regulations and guidelines • Ability to acquire knowledge, for example, about a new therapy area, quickly Competent • Proficient with support software, such as EndNote and Adobe Acrobat • Analyse and understand regulatory developments and their impact on assigned projects/documents • Excellent organisational and time management skills • Ability to work under pressure to agreed timelines and ability to multi-task TEAMWORK Expert • Accountability for the individual part of the project • Work effectively to share responsibility as a team member • Ability to work cooperatively with others to achieve overall goals • Receptive to ideas, feedback, and contributions • Commitment to delivering client and company requirements by demonstrating a willingness to help others outside the individual responsibilities • Sharing knowledge and keeping stakeholders up to date with current project status COMMUNICATION AND NEGOTIATION SKILLS Expert • Foster good interpersonal relationships • Build trust and respect with peers and clients • Ability to explain complex scientific issues clearly and confidently, both verbally and in writing Competent • Influence individuals or groups to reach consensus, achieve objectives, and mature documents QUALIFICATIONS • Life Science or Pharmacy Degree (PhD or equivalent preferred) • Qualified to work in the UK • Fluent in English • More than five years experience in regulatory medical writing Regulatory documentation includes but is not limited to: Regulatory Development – Scientific Advice, PIP, iPSP, ODD Clinical Trial Applications – Protocols, IBs, CSRs, IMPDs, ICFs (IND sections) Pharmacovigilance – DSUR, PSUR/PBRER Marketing Applications (NDA/BLA/MAA) – M2 overviews and summaries, product information Staging used in this job description: Expert (independent) / Competent (mostly independent) / Developing requires guidance

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