Procter & Gamble Pharmaceuticals Work Values

Daily Duties at Procter & Gamble Pharmaceuticals:

Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation. Prepare clinical submission documents for a regulatory audience, within a team environment, according to P&G SOPs and templates. Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner. Provide process, content, and submission/document planning expertise to project team. Advise team on resource utilization, efficiencies, timelines, and interdependencies. Lead the development of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards to foster open communication, quality, efficiency, and cost-effectiveness of clinical document generation to support the delivery of high-quality documents within realistic and ambitious timelines. Share expertise within Medical Writing by coaching/mentoring other Medical Writers. Represent Medical Writing on inter-departmental process teams.

What they like about Procter & Gamble Pharmaceuticals:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Regulatory Affairs, home based, PharmD, Word, Acrobat, Excel, eCTDXpress, OTCs, Medical Writing, Regulatory Strategy, Manager, Pharmaceuticals, Generics, INDs, NDAs, ANDAs, Clinical Development, clinical trial design, regulatory submissions, Phase 1-4, labeling, advertising, promotional materials, global, cross-functional team leader, ISI Toolbox, Documentum

Skills

regulatory strategy, regulatory submissions, communication, oral and written, people management, project management, medical writing, clinical trial design, protocol development, collaboration, creative problem solving, decision making, analytical assessment, MS Word, Adobe Acrobat, ISI Toolbox, eCTDXpress, MS Project, MS Powerpoint, Excel, Sharepoint, Documentum, grace under pressure, multitasking

These are some of the questions we asked our climbers about their experiences with Procter & Gamble Pharmaceuticals: