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.
About You – experience, education, skills, and accomplishments
- Graduate or Postgraduate in Life Sciences
- At least 5 years’ experience in pharmaceutical development, CMC manufacturing or CMC regulatory affairs, team management, stakeholder management etc
- Provide immediate supervision to a team or group of analysts/specialists who may share similar or identical assignments, as described below under management responsibility.
- Review and approve new terms for consideration where gaps or inconsistencies are identified within existing thesauri.
- Review the editorial team's performance and provide constructive and timely feedback.
- Successfully navigates the content management system and other editorial toolsets to ensure timely updates to databases, preparing and maintaining stats and other reports as needed.
- Play a key role on special projects as needed in support of emerging business needs.
- Strong knowledge of quality aspects of drug development and ICH requirements.
- Experience on submissions, post-approval changes, responses to deficiency letters and communications with health authorities on quality aspects of the product is required.
It would be great if you also had . . .
- Knowledge of Biological entities would be appreciated.
- Knowledge of another European language.
What will you be doing in this role?
- Oversee day-to-day operations and lead a team of colleagues.
- Plan, delegate, and direct the team’s day-to-day work to achieve operational targets or objectives with contribution to the immediate results for the team or department.
- Communicate policies, practices, and procedures within immediate area of responsibility to stakeholders within the team.
- Identify and lead team-level quality and process improvement initiatives.
- Provide input on staffing decisions for the team.
- Monitor the evolution of CMC regulatory landscape worldwide.
- Analyze the changes in the CMC requirements and implement them in the database. .
- Communicate relevant information to concerned stakeholders.
About the Team
The 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
Hours of Work
Hybrid work mode. Mon-Friday
At 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.
