Gcma Senior Associate
6 hours ago
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**:
**Your responsibilities**:
- Manage Key Opinion Leader (KOL) and vendor relationships to identify new areas of opportunity within the business strategic objectives.
- Contribute to development of scientific rationale to support United states Food and Drug Administration (FDA) submissions and other regulatory dossiers.
- Work with internal and external teams to support publication planning.
- Develop scientific communications including manuscripts, abstracts, symposia and sales force training materials.
- Manage timelines for internal review and approval processes of key documents.
- Support and enhance the professional messaging by effectively interpreting in-vitro, ex-vivo and clinical studies to improve communication with health care professionals.
- Broad medical science responsibilities and be involved in a combination of strategic and operational activities.
- Providing medical scientific support for such things as claims, brand support, research and development activities, medical strategy and evidence generation activities.
- Research, create and revise a variety of documents alongside the team for submission to Health Authorities (including Notified Bodies in Europe) globally to support clinical development and registration of RB products as well as to plan, execute and communicate evidence data both internally and externally.
- Build understanding of the literature, product data, competitors and current medical opinion and support the teams regarding new clinical data or medical press coverage.
- Plan and conduct of fair-balanced assessment of efficacy and safety data and provide advice on the best approach to drive brand growth.
- Serve as a technical point of contact for governance activities and collaborate with cross
- functional teams, ensuring the delivery of regulatory dossiers.
- Provide strategic direction to the team to resolve quality issues, formulation and analytical challenges, site transfers, cost savings and local new/existing product roll out.
- Contributing actively to all medical science aspects of the therapy area and being seen as a technical contributor.
- Manage research project budgets and contracts accordingly and compliantly.
- Ensure compliance with necessary standards.
**The experience we're looking for**:
- Bachelor's degree, preferably associated to healthcare or life sciences (such as Biology, Biomedical sciences, Pharmacy, Nursing or Medical).
- Further education such as MSc or PhD is beneficial
- Previous experience in a medical affairs, medical information or product support role
- Experience with OTC medicines / devices as required and experience with clinical development, clinical trials and regulatory dossiers.
- Experience of interpreting and communicating scientific information.
- Industry experience beyond medical and diverse experience of drug development or healthcare products
- Experience of creating and reviewing medically focused technical documents
- Experience of insight creation in healthcare
- Regulatory experience
- Code compliance and GCP
- Tenacious with a strong desire to influence others and collaborate - a proven team player
- Excellent communication skills
- An ablity to summarise and simplify scientific concepts
- Appetite for exploring new ideas and innovating
- Strong delivery focus and organisation skills
- Analytical mindset
- Organisation and the ability to prioritise under pressure
**The skills for success**:
- Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business Accumen, Commercial Awaren
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