Medical Affairs Coordinator

Overview:

As an integral member of the Medical Affairs Team, the Coordinator, MA Operations will provide project management and co-ordination for MA activities including management of Investigator-Sponsored Studies (ISS). The MA Coordinator will need to sit onsite at the East Windsor, NJ location. The position will be responsible for operational logistics and systems management as required.



The position will interact with several groups, which include, Regulatory, Pharmacovigilance (PV), Clinical Research, Operations, Medical Liaisons Team, Medical Information, Legal and Finance. The Coordinator, Medical Affairs Operations, will report directly to the Senior Director, Medical Affairs.



Responsibilities:

Coordinate and organize IIS Study discussions with internal decision making committee, Investigators and MSL to evaluate and approve programs. Tracks, monitors, participates in, and co-ordinate all aspects of IIS including concept processing and approval, contract drafting and finalization, management of study execution and close-out activities, access to study drug (when applicable), in close collaboration with internal colleagues (e.g. Finance, Legal, Scientific Review teams, Operations). Send SUSAR to IIS investigators as advised by global PV team.

Coordinate departmental meetings for IIS reviews. Responsible for meeting logistics, preparing meeting agendas, providing meeting facilitation, documenting meeting outcomes and follow-up and implementation of action plans.

Work with MA Team and Finance to raise Pos and track financial spends aProductst budget.

Provides Project Management support for MA activities.

Maintain Mondays system (data-warehouse of all medical projects).

Reporting and dashboard maintenance for Medical Affairs activities across department

Assist in publication planning and annual medical planning under direction of the Senior Director.

Work requires the consistent exercise of discretion and judgement.

Collect incoming inquiries from ProPharma Medical Team and forward to relevant departments such as Quality, Medical and PV.

Enables active cross-functional communication among different MA functional contributors (or leads) through appropriate methods.

Develops and maintains presentation slides, spreadsheets and other summary documents and/or databases relevant to the department operational strategic and tactical plans.





Qualification:

Strong coordination, administrative skills and general operational management.

Good understanding of MA and comprehensive understanding of the compliance issues concerning MA function.

Knowledge/application of data sources, reports and tools for the creation of solid plans.

Strong communication and presentation skills.

Excellent computer skills: Excel, Word, PowerPoint, etc.

Desire to learn science and grow in the role.





Education and Experience:

Bachelor of Science/Arts degree required

2+ years of Pharmaceutical/Biotechnology industry experience

1+ year of Medical Affairs experience preferred

Proven Project Management/co-ordination experience and expertise is required

Demonstrated success in establishing successful working relationships with a diverse range of internal and external stakeholders.

Must be a dependable self-starter. Must be capable of working independently on multiple projects with the ability to prioritize tasks and meet strict deadlines.

Must possess excellent organization skills, and be able to operate effectively in a fast growing organization, where a demanding workload requires balancing multiple responsibilities simultaneously.

Must possess excellent communication and interpersonal interaction skills.

Must be legally able to work in the US without requiring sponsorship.

Must have reliable transportation and must be able to work overtime when required.