The Associate Director, Registry Operations supports PTC’s Registry function in study-related activities as assigned. The Associate Director works under the supervision of the head of the Registry function within the Medical Affairs Department to provide high level support in project/program delivery.
The incumbent works cross-functionally with internal departments and external resources on registry-related issues.
The Associate Director may manage direct report(s).
The Associate Director supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Performs all operational activities to support the head of the Registry function with all study related activities in a timely and accurate manner.
Interacts and liaises with internal and external partners as needed. This includes, but may not be limited to, Contract Research Organizations (CRO's), agencies or others as required.
Works with team to identify CRO's; manages and oversees CRO's for assigned study(ies).
Prepares investigational site lists and participates in the review and approval of investigational sites; negotiates contracts and budgets with sites and vendors and presents to the project team for approval.
Plans, coordinates, and conducts investigator meetings including presentations at the meetings; responds to questions from sites and trial monitors regarding trial conduct.
Manages registry timelines using the appropriate project management tools; manages expenditures for registry study, including those for investigational sites and vendors.
Contributes to the organization of global and local investigator meetings by supporting the head of the Registry function and Medical Affairs team members in the country(ies).
Processes invoices in a timely and accurate manner. Tracks the same.
Maintains and disseminates study-specific reporting information internally as needed.
Prepares presentations for line manager meetings, department meetings or program meetings as required.
Writes meeting minutes. This includes, but may not be limited to, vendors meetings and team or department meetings.
Performs other tasks and assignments as needed and specified by management.
Bachelor’s degree in a relevant discipline, preferably in a scientific field, and a minimum of 7 years of experience in a pharmaceutical, biotechnology or related environment OR equivalent experience and/or education.
* Special knowledge or skills needed and/or licenses or certificates required.
Demonstrated experience coordinating assigned projects in a timely and accurate manner.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Hands-on experience supporting and understanding Good Manufacturing Practice, (GMP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines.
Experience working in multicultural, multilingual environments.
Flexibility and ability to work under pressure.
Excellent verbal and written communication and skills including fluency in written and spoken English.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
* Travel requirements: 20-30%
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.