CultureHQ

Director

• Leverage account management and/or build strong partnerships with targeted accounts with C & D suite population-based decision makers (PBDMs)
• Sustains long-term customer partnerships with assigned accounts, based on a deep understanding of the customer organization, structure, business strategy, and priorities.
• Ability to build effective business plans that align with access goals to support brand and market access strategies
• Strong knowledge of oncology or allergy provider landscape and prominent accounts
• Effectively communicate value propositions for current product portfolio
• Provider contract experience and contract management/pull-through to support GPO contracts for Cogent brands
• Conduct internal and external business reviews across aligned accounts with Cogent functions and Provider PBDM customers (Dir. of Pharmacy, Medical Directors, Dir of Contracting etc.)
• Effectively lead contract negotiation and execution, including pre-contract financial ROI analysis, contract language negotiation, pull through development and execution, post contract measurement and analysis and formulary communication strategy.
• Support access and on-label integration into provider decision making platforms (ex. EMRs and acct level pathways, if applicable) along with medical support.
• Translate the voice of the PBDM customer into accountable and actionable insights to support Brand & MA strategies
• Support product access at the EMR, formulary and Acct level pathways, if applicable with Medical Support, (varies by account)
• The ability to partner with cross functional partners including Sales, Medical, Marketing, HEOR, Patient Support and Contracting, as needed
• Develop and maintain an integrated business plan which illustrates account overviews, monitors contract progress and performance, and account penetration at the enterprise and local level.
• Provide in-depth analysis related to accounts, market trends, competitive activity, contract performance, and personnel.
• Communicate regularly to senior management for the opportunities, challenges, and performance of accounts.
• Ensures strategies and KPIs are implemented and monitored to achieve our commercial goals while working within the assigned budget.
• Works within Cogent’s compliance policies

Director, Corporate Accounts

Manager

• Supports early-stage and late-stage development products.
• Oversight of day-to-day safety monitoring activities of clinical trials for the assigned product(s).
• Perform signal management activities including – signal detection, analysis, and tracking for the assigned product(s).
• Effectively collaborate with stakeholders outside of PV, including representing PV department in cross-functional clinical programs.
• Participate in Safety Committees (e.g., Safety Management Team and Independent Data Monitoring Committees meetings); may include coordinating data, slide creation, data presentation, agenda drafting, and minutes.
• Provides PV input for development of protocols, Investigator’s Brochure, Informed Consent Forms, Clinical Study Reports, and other relevant study documents.
• Contribute to authoring of aggregate safety reports, e.g., DSURs.
• Contribute to regulatory responses while collaborating with cross-functional areas as necessary.
• Participate in developing, implementing, and maintaining processes that are compliant with global PV regulations.
• Perform other tasks as assigned by the team.

Senior Manager, PV Scientist

Content Writer

• Lead planning, authoring, reviewing, and QC of clinical and regulatory documents
• Facilitate document reviews and lead consensus meetings among stakeholders
• Ensure consistent messaging across documents
• Represent Medical Writing department on clinical study teams
• Perform/manage quality control reviews of clinical and regulatory documents
• Collaborate with/manage contract writers
• Contribute to development/implementation of medical writing processes
• Adhere to regulatory standards and company SOPs

Senior Manager, Medical Writing

• Subject matter expert for all aspects of drug substance process and controls.
• Manage development and manufacturing activities at drug substance CDMOs.
• Lead small molecule drug substance route selection/evaluation, scale up, and process control development including identification of critical process parameters, critical quality attributes, and acceptance criteria.
• Review and approve external vendor documentation including protocols, reports, raw data, master and executed batch records.
• Perform impurities fate analysis and manufacturing process parameters assessment and develop an overall end-to-end control strategy.
• Lead solid state evaluation and development activities to support process control, formulation development, and intellectual property protection.
• Provide drug substance support for quality events including deviation investigation, corrective and preventative action implementation and change control for both internal and external operations.
• Author, review, and approve documents in support of regulatory filings including module 3 sections of Investigational New Drug (IND) applications and New Drug Application (NDA) as well as CMC section in a global regulatory submission.
• Provide guidance as a subject matter expert in drug substance manufacturing and development for internal CMC and discovery organization.
• Provide on-site support at external suppliers including project initiation, routine visits and technical leadership as needed.

Director, Corporate Accounts

Senior Manager, PV Scientist

Senior Manager, Medical Writing

Associate Director – Drug Substance Manufacturing & Development