PURPOSE OF THE FUNCTION
Accountable for the operational activities including the planning, conducting, and completing post-marketing studies globally (excluding Japan) in compliance with regulatory requirements.
Plan, coordinate, and manage the selection and operations of CROs and other study vendors. Location can be EU or US with ability to travel internationally a few times per year.
ROLES AND RESPONSIBILITIES
- Drive the conduct of the PMRs or other non-interventional safety studies, ensuring that study milestones are met (including site selection, enrolment targets, interim reports) in accordance with protocols and regulatory requirements.
- Manage and actively contribute to project planning and budgeting as related to PMRs.
- Maintain adequate trackers, metrics, and progress reports regarding budget, timelines, deliverables, and documentation.
- Ensure timely collection, documentation and reporting of Adverse events (AEs) and Serious AEs (SAEs) in collaboration with Operations.
- Identify, communicate, and manage potential study risks regarding study start up, conduct, data management, analysis, and monitoring.
- Lead CRO and vendor selection and negotiations in collaboration with client vendor management.
- Oversee and actively collaborate with study vendors and consultants.
- Collaborate closely with other departments including Quality, Medical Affairs, Regulatory, Finance, and Legal on issues and potential solutions.
- Oversee and / or contribute to the development and maintenance of study documents including ICFs, protocols, adverse event reporting forms, as well as SOPs or other procedural documents.
- Support the preparation of publications as needed.
- Actively participate in site or vendor audits and inspections.
- Transparently communicate and / or escalate issues to client leadership as needed.
- Promote and implement innovative processes and continuous improvement initiatives as needed.
- May perform other tasks as assigned by client leadership.
SKILLS AND COMPETENCIES
- Excellent presentation skills with the ability to communicate complex issues clearly
- Excellent planning and organizational skills with ability to manage competing priorities
- Excellent oral and written English communication skills
- Ability to motivate, influence, and collaborate with multidisciplinary teams
- Ability to work independently and in a global environment
- Robust understanding of safety business processes and systems for the collections of adverse events
- Problem solving, conflict resolution and critical thinking skills
- Demonstrated ability to author or contribute to complex documents project plans, protocols, study reports, or regulatory submissions.
- Advanced computer skills, including data collections systems and proficiency with Microsoft Office Suite
- Fluency in written and spoken English
EDUCATION, EXPERIENCE AND QUALIFICATIONS
- Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field
- At least 5 -7 years of experience in the pharmaceutical / biotech industry
- At least 3 years of experience in clinical operations, post-authorization studies and other post-marketing pharmacovigilance requirements
- Demonstrated project management skills
- Demonstrated experience with planning and managing study operations
- Ability to manage CROs or other clinical service providers
- Working knowledge of pharmacovigilance regulatory requirements worldwide
- Expert knowledge of the drug development process, GXP quality and compliance requirements
Senior Technical Product Marketing Manager
Own the Qualys bottom and middle of funnel content editorial strategy and calendar, working closely with outbound marketing team and product marketing to curate company objectives with content requirements. This is a high-visibility, high impact role, you will work closely with product management an...
Senior Email Marketing Manager
The Senior Email Marketing Manager will be responsible for the development and execution of our email marketing strategy to drive increased brand awareness and customer acquisition. You will build impactful customer campaigns, crafting lifecycle marketing flows for prospective B2B customers while re...
Senior Product Marketing Manager - TheraNest
Therapy Brands is seeking a senior product marketing manager to lead the product marketing efforts for our flagship TheraNest product. Reporting to the vice president of product marketing, you will work closely with demand generation, corporate marketing, sales, and product management teams to grow ...
Senior Product Marketing Manager, Amazon Sagemaker, Aws Aiml Product Marketing Team
Manager, Product Marketing Manager to our team to drive these exciting initiatives!. The product marketing team works on creating compelling positioning and marketing content to support product launches and campaigns that will help customers do more with generative AI. Are you excited about going de...
Senior Product Marketing Manager
Constant Contact Product Marketing is seeking a senior product marketing manager to support exciting advancements to our digital marketing platform. You will need to be able to adapt quickly to new circumstances, and foster strong relationships across product, sales and marketing teams, while collab...
Lifecycle Marketing Senior Manager
The Senior Manager, Rx Marketing is responsible for strategy development of the retail pharmacy email and owned channels. We are looking for innovative marketing leaders who think big and push boundaries to drive business result with the consumer at the center. You will be a part of an exciting grou...
Senior Product Marketing Manager (Marketing Cloud)
The Salesforce Marketing Cloud Product Marketing team works across technology, product, sales, and marketing to position and promote the #1 Marketing Cloud in the industry. Work closely with the industry experts and Analyst and Press Relations teams to ensure effective thought leadership and ongoing...
BlackBerry QNX Senior Product Marketing Manager (QNX Sound)
Your marketing experience coupled with a technical/engineering background, will be highly advantageous in understanding customer pain points and requirements to tailor messaging and value propositions accordingly. Create impactful marketing content, including presentations, brochures, blogs, videos,...
Senior Product Manager, Vaccines Marketing, US
About The JobYou will report to a senior leader of marketing in the Vaccines Marketing group and will be a key member of the Vaccines Marketing and Commercial Strategy Team driving the success of vaccines and products in either RSV, Flu, or the Sanofi portfolio of vaccines. Senior Product Manager, V...
Senior Customer Marketing Manager
Senior Customer Marketing Manager. Senior Director, Customer Engagement Marketing. Bachelor's degree, emphasis in marketing, analytics or related subject preferred. Ability to coordinate, manage, and execute multiple marketing campaigns at the same time. ...