We are looking for a Team Manager, Stem Content Analysis to join our CMC Regulatory Market Access team. This is an amazing opportunity to work on the product.
nAbout You experience, education, skills, and accomplishments
- nGraduate or Postgraduate in Life Sciences
- nAt least 5 years experience in pharmaceutical development, CMC manufacturing or CMC regulatory affairs, team management, stakeholder management etc
- nProvide immediate supervision to a team or group of analysts/specialists who may share similar or identical assignments, as described below under management responsibility.
- nReview and approve new terms for consideration where gaps or inconsistencies are identified within existing thesauri.
- nReview the editorial team's performance and provide constructive and timely feedback.
- nSuccessfully navigates the content management system and other editorial toolsets to ensure timely updates to databases, preparing and maintaining stats and other reports as needed.
- nPlay a key role on special projects as needed in support of emerging business needs.
- nStrong knowledge of quality aspects of drug development and ICH requirements.
- nExperience on submissions, post-approval changes, responses to deficiency letters and communications with health authorities on quality aspects of the product is required.
nIt would be great if you also had . . .
- nKnowledge of Biological entities would be appreciated.
- nKnowledge of another European language.
nWhat will you be doing in this role
- nOversee day-to-day operations and lead a team of colleagues.
- nPlan, delegate, and direct the teams day-to-day work to achieve operational targets or objectives with contribution to the immediate results for the team or department.
- nCommunicate policies, practices, and procedures within immediate area of responsibility to stakeholders within the team.
- nIdentify and lead team-level quality and process improvement initiatives.
- nProvide input on staffing decisions for the team.
- nMonitor the evolution of CMC regulatory landscape worldwide.
- nAnalyze the changes in the CMC requirements and implement them in the database. .
- nCommunicate relevant information to concerned stakeholders.
nAbout the Team
nThe team consists of 9 colleagues and reports to the Senior Team Manager. Regulatory Intelligence information is part of Life Science and comprises several teams responsible for the daily collection, synthesis, and maintenance of data relating to regulatory information. These records form a core element of the Product
nHours of Work
nHybrid work mode. Mon-Friday
nAt Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
