Technical Reviewer - Promotional Compliance
Hendre Moolman at CK Clinical is currently recruiting for a Technical Reviewer - Promotional Compliance for a global pharmaceutical company on a contract basis. This is an office based role in Buckinghamshire.
Main duties and responsibilities:
- Undertaking review of international promotional copy (materials and activities) in accordance with relevant compliance principles and company SOP's.
- Participating in international brand teams, providing compliance guidance in the development of international promotional copy.
- Facilitating the Business Unit/function to create programs, activities and materials that can be approved and released for use internationally and in-country in line with required procedures, including the development of usage instructions/guidance for individual programs, activities and materials.
Additional responsibilities include:
- Planning, writing, editing, reviewing and coordinating the publication of compound documents and other regulatory/ disclosure data.
- Facilitating trial development and product registration.
- Ensuring and coordinating quality checks for accuracy, collating reviewer's comments, adjusts content of document based on internal/external input, and prepare final version.- Exhibiting flexibility in moving across development and preparation of multiple document types.
- Working with teams to ensure smooth and timely development of documents.
- Influencing or negotiating change of timelines and content with other team members.
- Effectively collecting and evaluating information from multiple sources.
- Building / managing relationships with vendors / alliance partners.
- Providing oversight on individual deliverables, including timeline management, delivery of feedback and issue management.
- Maintaining and enhancing therapeutic area knowledge including, disease state and compound for assigned project.
- Exhibiting flexibility in moving across therapeutic areas and compounds, depending on project assignment.
- Maintaining and enhancing knowledge of regulatory guidelines and publication guidelines.
- Possessing overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.
- Providing informal coaching to others by sharing technical information, giving guidance, answering questions.
- Networking with others to identify and share best practices globally.
- Contributing to process improvements, suggesting opportunities where appropriate.
- Providing database and other tool (eg, document management systems) expertise.
- Engaging in activities supporting reward and recognition, team building, and diversity.
- Supporting cross-functional coaching, mentoring, and training.
- Working with internal and external speakers to develop and prepare presentations.
- Bachelor's Degree.
- Proven experience in drug development.
- Demonstrated mastery of written English with experience in medical, scientific or technical writing fields (at least 1 year); professional verbal skills in English.
- Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability.
- Demonstrated project management and time management skills.
- Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
- Demonstrated high-level end-user computer skills (e.g. word processing, tables and graphics, spreadsheets, presentation and templates).
- Ability to work well across cultures and time zones.
- Clinical Pharmacology experience.
- Medical and scientific knowledge and experience (e.g. neuroscience, oncology, cardiovascular, or endocrine expertise).
- Experience and knowledge of clinical trial process or regulatory activities.
- Experience writing regulatory or clinical trial documents.
- Publication experience.
- Ability to work well independently and as part of a team.
- A writing exercise may be required as part of the candidate evaluation process.
- Limited travel, up to approximately 10%.
For more information or to apply for this role, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34596 in all correspondence.