Project Manager, Global Medical Affairs Research Oncology

Foster, CA - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.

Position: Project Manager Global Medical Affairs Research Oncology

Location: Foster City CA 94404

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Job Description:

Global Medical Affairs Research plays a key role in developing Integrated Evidence Plans (IEPs) that include a holistic view of prioritized data needs across the product lifecycle.
We are seeking a well-organized professional to join the Global Medical Affairs Research team reporting to the Senior Director of Medical Affairs Research Oncology Team Lead.
This role will provide operational and logistical support to the IEP Teams across all tumor types within our oncology therapeutic area.
This contractor will serve as the primary project management lead for Oncology IEP Teams ensuring that all operational workflows timelines documentation and cross-functional communications are executed with precision and consistency.
The ideal candidate will have solid experience as a project manager.
Within global medical affairs research for Oncology the position will work to ensure all steps of the MA research proposal review are well documented compliant and consistent with standard operating procedures; evaluate and implement best practices within the Oncology department.
The candidate must have a professional demeanor representing clients core values of integrity inclusion teamwork accountability and excellence in every project.

Specific Job Responsibilities:

Management of Oncology IEP Execution Teams

Manage IEP team meetings and workshop logistics: schedule in Outlook confirm attendance of key participants prepare and distribute meeting agendas slides and other materials
Capture and distribute meeting outcomes action items and timelines following up with team members to ensure timely execution of ET deliverables
Manage rosters and distribution lists
Maintain Study Trackers and Data Generation Summaries by collecting updates from team members on a quarterly basis
Support the creation of quarterly and ad hoc executive update reports
Assist with refinement and standardization of IEP processes and tools across therapeutic areas to ensure that the best practices from one therapeutic area are incorporated into other areas
Serve as the day-to-day operational owner of the Oncology IEP data generation trackers ensuring real-time accuracy of study status timelines dependencies risks and cross-functional inputs
Coordinate scheduling agenda development and minutes for all Oncology IEP-related meetings including follow-up communications and deadline reminders.
Monitor deliverable progress flag delays and proactively escalate risks to leadership.
Provide operational support during IEP annual refresh cycles including aligning timelines coordinating stakeholder interviews and consolidating updates.

Knowledge & Skills:

Established project management process improvement and organizational skills including management of multiple priorities and resources while maintaining attention to detail
Excellent verbal written and interpersonal skills are required
Proven track record of executing clearly defined goals and objectives in a fast-paced environment
Self-motivated to work independently and have a positive attitude while working as part of various teams
Ability to apply logic and problem-solving skills under pressure and adapt to change
Strong business skills/acumen and documentation practices
Knowledge and skill with Smartsheet Microsoft Excel Word PowerPoint Outlook and other reporting and tracking tools
Strong meeting facilitation capabilities including managing agendas documentation and complex stakeholder coordination.
Experience maintaining complex trackers dashboards or operational tools supporting cross-functional research teams.
Ability to translate meeting discussions into clear action items responsible owners and timelines.

Education & Experience:

Masters degree (eg MS MPH) with 4 Years experience; OR Bachelor of Science degree with 6 years of experience in the pharmaceutical industry and/or project management
Must be fully cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations ICH guidelines and GCPs governing the conduct of clinical trials
Comprehensive understanding/experience in interventional and observational research or experience in MA/pharmaceutical industry; 3-5 years in medical affairs-related programs or devlopment

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focu...