Process History Files Scientific Writer Msat

Job responsibilities include some of the following Product Process Knowledge Management Data gathering Product Quality Review Change Requests Methods of Production Genealogical tree and quality reporting PHF Parking lot document with the pending point of the previous version of PHF Manage PHF governance operational follow up meetings kick off consolidation follow up Write update the PHF s with information gathered and manage the approval process with identified stakeholders PHF Publishing in Veeva Manage AAR with stakeholders PHF continuous improvement Collaboration and Communication Work collaboratively with various departments including MSAT discipline experts QA GCC associates Documentation and right first time Ensure the consistent quality of the PHF s Innovation Identify opportunities for innovation based on scientific advancements and emerging trends IA digitalization Training and Development train staff and stakeholders on best knowledge management practices in close collaboration with MSAT information and knowledge management experts Checking that the PHF knowledge management strategy laid out by the Global MSAT Compliance and Knowledge Management Process Excellence lead is being respected Basic Qualifications Bachelor s Degree ideally with a Ph D in a relevant scientific discipline e g biology chemistry pharmacy Experience at least 10-16 years of experience in pharmaceutical or biopharmaceutical MSAT or a related field A working experience of at least 3 years as a scientific writer or in a similar role is key asset Stakeholder engagement experience in an international and matrixial environment Advanced scientific writing skills and capabilities Strong communication team management skills and interpersonal skills Strong attention to detail and ability to produce high-quality accurate documents Uphold the highest standards of scientific integrity and ethics Analytical and problem-solving skills Strong knowledge and understanding of Pharmaceutical or Biopharmaceutical environment Knowledge and understanding of Good Manufacturing Practice GMP Knowledge of regulatory requirements and industry standards Advanced Written and oral fluency in English Office tools Classical word excel PowerPoint and specific Office Timeline Pro pdf creator Documentum SAP GSK Access PHF PQR general R D doc Techshare Veeva GSK Access Preferred Qualifications MSAT or Manufacturing Science and Technology is a critical function within a pharmaceutical and biopharmaceutical manufacturing organization in general The GSK MSAT team is responsible for ensuring that products are produced safely efficiently and to the highest quality standards Why GSK Our values and expectations are at the heart of everything we do and form an important part of our culture These include Patient focus Transparency Respect Integrity along with Courage Accountability Development and Teamwork As GSK focuses on our values and expectations and a culture of innovation performance and trust the successful candidate will demonstrate the following capabilities Agile and distributed decision-making - using evidence and applying judgement to balance pace rigour and risk Managing individual and team performance Committed to delivering high quality results overcoming challenges focusing on what matters execution Implementing change initiatives and leading change Sustaining energy and well-being building resilience in teams Continuously looking for opportunities to learn build skills and share learning both internally and externally Developing people and building a talent pipeline Translating strategy into action - a compelling narrative motivating others setting objectives and delegation Building strong relationships and collaboration managing trusted stakeholder relationships internally and externally Budgeting and forecasting commercial and financial acumen Why GSK Uniting 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 it s 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 Agencies GSK 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 authorization before referring any candidates to GSK The obtaining of prior written authorization is a condition precedent to any agreement verbal or written between the employment business agency and GSK In the absence of such written authorization being obtained any actions undertaken by the employment business agency shall be deemed to have been performed without the consent or contractual agreement of GSK GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses agencies in respect of the vacancies posted on this site It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for recruitment process Please do not make payments to any individuals entities in connection with recruitment with any GlaxoSmithKline or GSK group company at any worldwide location Even if they claim that the money is refundable If you come across unsolicited email from email addresses not ending in gsk com or job advertisements which state that you should contact an email address that does not end in gsk com you should disregard the same and inform us by emailing askus gsk com so that we can confirm to you if the job is genuine