Risk Evidence Writer

We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Research & Development

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

About The Role

The Risk Evidence Writer authors and inputs into various Vigilance and safety documents which are fundamental to the Reckitt product risk-benefit evaluation and risk management process, ensuring accurate, evidence-based and consistent safety messaging, as well as optimising and maintaining appropriate risk minimisation activities for the protection of consumers.

The Risk Evidence Writer collaborates with relevant teams and functions and conducts standard scientific literature searches to produce evidence-based reports/position statements. These documents will be used by the business for product benefit-risk analyses and risk management activities, and for use in product safety defence, assessment and Competent Authority responses (e.g. PRAC, RFI and switch documentation).

The Risk Evidence Writer inputs into of all aspects of the Reckitt global signal management process, including signal surveillance for medicines, medical devices, cosmetics and other Reckitt products. The role will collaborate with multiple functions across the Global Safety Assurance group, and support various product development and maintenance projects regarding utilisation of adverse event/signal data for benefit-risk and safety risk minimisation activities/optimisation strategies.

As part of the Risk Management and Vigilance Team, the Risk Evidence Writer will be involved from product ideation/conception through to post-marketing safety review activities to help shape the safety risk minimisation activities, and input into safety messaging communications to limit and manage the risk of human harm to Reckitt consumers.

Your responsibilities

• A minimum of 6 years in regulatory affairs, product safety or vigilance, crafting strategies and guiding teams through submission processes.
  
  

The Risk Evidence Writer has established scientific writing skills and can produce high quality, accurate and balanced documents to develop the guidance and company positioning for evidence-based benefit-risk strategies, and evidence synthesis activities for the benefit-risk safety assessments of Reckitt products. Additionally, the Risk Evidence Writer will drive the global signal management process implementation and signal data application for product safety core risk analysis, risk minimisation activity development and communication, as well as support signal detection systems deployment, maintenance, statistical data analysis protocols and training. The Risk Evidence Writer also collaborates with relevant functions and personnel on the research oversight of safety risk activities, as appropriate.

• Has demonstrable scientific writing and effective science communication skills.
• Supports literature search protocols and strategies by developing standardised scientific literature search strings (e.g. Emtree, MeSH).
• Conducts scientific literature searches and can critically appraise the output with preliminary synthesis of conclusions and safety position statements for internal and external use.
• Produces succinct and business accessible scientific evidence review reports.
• Supports the production of safety reports and position statements with benefit-risk and safety risk minimisation analysis input for general regulatory submissions (e.g. RMP, CCDS, request for information) and safety position generation across the RB product portfolio.
• Follows the overall signal management surveillance process and strategy across all Reckitt products (including medicines, medical devices, cosmetics and other products)
• Effectively communicates and escalates emerging safety signals as appropriate
• Inputs into the Regulatory and Safety processes for risk and core safety validation and communication.
  
  

The experience we're looking for

 Minimum bachelor’s scientific degree essential and post-graduate qualification desirable.

 Relevant vigilance/pharmacovigilance or related product safety experience e.g. safety documentation authoring/review

 Experience across a broad range of therapeutic areas

 Previous Experience Of Regulatory Medical Writing Is Essential

 Ability to critically appraise scientific data across multiple therapeutic areas

 Strong project management and organisational skills

 An appreciation and understanding of global medicines and medical device regulations

The skills for success

Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business accumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, Creative Direction, R&D, Change Leadership, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Relationship Management, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes, Digital transformation for R&D, Quality and Manufacturing.

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

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