Medical Writer

City: Shanghai

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.

About the role

The role of Medical Writer is integrated within Global Medical Science and reports directly to the Medical Writing Manager. This is a crucial role, requiring the successful applicant to take responsibility for writing, editing and maintaining high quality Medical and Clinical documentation for Regulatory submissions, which is essential for business growth and building a strong reputation with Health Authorities, as well as facilitating and supporting the on-going marketing of Reckitt medical devices, cosmetics, medicines and general products.

The Medical Writer will research, create and revise various documents associated with clinical research. Working closely alongside team members, the Medical Writer will ensure that all written documentation meets the strategic objectives and is produced to the highest possible scientific and editorial standards.

Your responsibilities

• Manage the writing, editing and reviewing of diverse Regulatory and Clinical Documents. These include but are not limited to: briefing documents, investigators’ brochures, clinical evaluation reports (CERs) and other Medical/Regulatory documents

• Provide input and edit/review of Regulatory and Clinical documents, as required, across all Reckitt product classifications, i.e. medical devices, cosmetics and medicines

• Manage the quality, accuracy and compliance with internal and external standards and the timely production of English and Mandarin language documents using electronic document management system

• Collaborate with subject matter experts across multiple departments to ensure quality and technical accuracy of documentation

• Develop, implement and manage templates for the standardisation of Regulatory and Clinical Documentation to support development and registration activities

• Develop an understanding of the regulatory landscape and documentation requirements for Medical Device registration in China

• Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to guidelines/SOP’s including: distribution of drafts, chairing review meetings, incorporating revisions and completing sign off procedures

• Coordinate and collate high quality responses to Regulatory questions that arise during dossier/technical file review as required

• Review, improve and maintain existing documentation and create and maintain audit system/trails of all document changes and respond to Medical Information requests

The experience we're looking for

• Bachelor’s degree preferably healthcare or life sciences (or equivalent)

• Experience in preparing medical or scientific documents to a high standard is essential. Experience of working in or for the Healthcare OTC industry, and/or direct experience of drafting documentation to international Regulatory standards is desirable

• Ability to understand complex clinical documentation and to critically appraise internal and external data for accuracy and robustnessDemonstrated knowledge of Medical Device/drug development processes and understanding of healthcare compliance laws and guidelines is desirable

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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