[Urgent Search] Principal Medical Writer

Years of Experience 9 to 12 yearsSkill Set Exposure PV background DSUR PBRER Addendum to CO PADER PAER and Risk Management Plans The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of safety documents e g aggregate reports and Risk Management Plans RMPs and interpretation of safety data They must demonstrate the ability to independently manage the production of safety deliverables including those involving complex data analyses or important safety issues This role requires extensive safety document expertise and will support continuous improvement and the implementation of best practices and adoption of new tools and technology Key Responsibilities Independently lead preparation of complex clinical and post-market safety documents including but not limited to Development Safety Update Reports DSURs Periodic Safety Update Reports Periodic Benefit-Risk Evaluation Reports PSURs PBRERs Addendums to Clinical Overviews ACOs US Periodic Adverse Drug Experience Reports Periodic Adverse Experience Reports PADERs PAERs RMPs and responses to regulatory authority questions Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work contributions Lead cross-functional teams in document preparation including but not limited to development of content strategy coordination of content contributions organization of review schedules and project timelines Work in a matrix team to ensure delivery of high-quality fit-for-purpose documents that reflect accurate interpretation of associated safety clinical and statistical data and are in line with GSK standards and global regional and or local regulatory requirements Understand the interdependencies of various contributing functions e g safety regulatory clinical epidemiology statistics and programming Anticipate and evaluate complex situations and problems resolving them by leveraging scientific and operational knowledge in collaboration with stakeholders Assess trends and patterns in text and statistical data and effectively organize content and messages in safety documents Use approaches to expedite document preparation including authoring and reviewing tools as well as other automation technology platforms Serve as a mentor for less experienced writers Develop and deliver training on medical writing topics Lead initiatives to improve medical writing processes Contribute to vendor oversight as needed Education Requirements Masters degree or equivalent in a scientific discipline A degree in Medicine Dentistry Physiotherapy Experimental Medicine which involves patient exposure in a hospital-based environment would be an advantage Job Related Experience Minimum of 7 years of advanced safety writing experience in the pharmaceutical domain including summarization and interpretation of complex data and preparation of complex documents In depth working knowledge of Relevant regulatory guidance e g ICH GVP FDA EMA pertaining to clinical trial conduct pharmacovigilance and document-specific requirements Core cross-functional clinical research roles and procedures and how they relate to document strategy and operational preparation Experience in multiple therapeutic areas to have confidence to dive into these areas without lead time Advanced understanding of and ability to apply the statistical regulatory and medical communication concepts needed to independently write complex safety documents Other Job-Related Skills Advanced safety writing skills with expertise in most safety document types Highly collaborative capable of leading crossxe2x80x90functional team members negotiating solutions and advising them on document structure and content as needed Skilled in navigating multicultural settings ensuring effective collaboration with diverse customers and clients such as health authorities and patients while adeptly collaborating with remote teams Able to independently lead multiple projects simultaneously and deliver multiple high-quality documents on schedule Advanced computer skills and general computer literacy Excellent English language proficiency both verbal and written Inclusion at GSK As an employer committed to Inclusion we encourage you to reach out if you need any adjustments during the recruitment process Please contact our Recruitment Team at IN recruitment-adjustments gsk com to discuss your needs Why GSKUniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose to unite science technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns as an organisation where people can thrive We prevent and treat disease with vaccines specialty and general medicines We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas infectious diseases HIV respiratory immunology and oncology Our success absolutely depends on our people While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be A place where they can be themselves feeling welcome valued and included Where they can keep growing and look after their wellbeing So if you share our ambition join us at this exciting moment in our journey to get Ahead Together Important notice to Employment businesses AgenciesGSK does not accept referrals from employment businesses and or employment agencies in respect of the vacancies posted on this site All employment businesses agencies are required to contact GSK s commercial and general procurement human resources department to obtain prior written 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