TRABAJO REGULATORY AFFAIRS LEAD STUDY BARCELONA, BARCELONA

Provide/roll out guidance and training to the western europe business relating to regulatory requirements... overview are you interested in a career in r&d in pepsico?...

The rid will work closely with therapeutic area (ta) vp, executive regulatory science directors, global regulatory leaders (grls) and regulatory affairs directors...

Accountabilities: leads the delivery of the clinical study from concept to final csr and through to study closure and archive to agreed budget, time, project standards...

Support the study team in the implementation of audits and regulatory inspections... support risk management and quality efforts to ensure study compliance...

Position summary the international medical review lead reports into the sr...   principal responsibilities medical review works collaboratively and develops good...

Effectively manage stakeholder relationships, including commercial, legal, and regulatory partners... lead cross-functional teams effectively, fostering collaboration...

Work closely with regulatory affairs to prepare and submit documentation for regulatory approvals and compliance... strong knowledge of regulatory requirements...

• ability to lead challenging priorities... • experience in all phases of a clinical study lifecycle... • extensive knowledge of clinical research regulatory requirements...

The lead will take on a lead role for specific european and international markets and support/lead specific gmap or regional projects and initiatives... accountabilities/responsibilities...

The principal clinical data science lead will provide input into crf design, protocol review, edit check specifications, data entry conventions, monitoring guidelines...

Familiarity with regulatory requirements around data security, privacy, and retention... desired qualifications: master’s degree in computer science, business administration...

Maintain compliance with all company compliance and regulatory guidelines governing external interactions...   participate in monitoring study progress, all...

As lead pm, you will sit on top of the “baas and payments” product direction, consisting of 3 squads with pos and tech leads... a direct manager of up to five pos...

(inter)national coordinating investigators, steering/executive committee) during study design and delivery   manage study finance:    develop and maintain the overall...

You will be responsible for: • assist global study teams (gsd, gsad, gsms) and support study deliverables by completing delegated study and functional activities...

Prepare various official and regulatory documents for regulatory and other agencies, such as dossiers, blas, inds, safety and annual reports, handling of responses...

Prepare and provide input to clinical study reports (csrs) and clinical portions of regulatory documents (e... ib, dsur, psur, regulatory responses) participate...

Develop relationships with appropriate consultants and key external experts (kee), study sites, and utilize these relationships to obtain feedback on protocol design...