Job description
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Location/Division Specific Information
Location: Collegeville, PA - Can be Remote
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
A day in the Life:
As an Associate Project Manager in this role you will contribute to internal and external development of the Client's specialty drug products and/or development of Strategic External Development's (SED)’s internal processes.
This role will provide you the opportunity to coordinate and support key product development activities while gaining knowledge of biopharma product development. These responsibilities include some of the following:
- Assist SED workstream leaders and technical teams to coordinate and facilitate project deliverables by:
- Scheduling CMC matrix/workstream/technical meetings
- Preparing meeting agenda
- Issuing minutes, tracking decisions and action items
- Following up on action items to ensure completion through collaboration with SMEs
- Project resource planning and reporting of project forecasts and actuals through internal planning systems (i.e. IRM, ET, Spotfire dashboards)
- Maintain detailed CMC dashboard to support SED visibility into program timelines, deliverables and risk profiles
- Manage OneNote as source for project information
- Track detailed technical deliverables and provide outlook on future deliverables
- Track submission source documents, including data verification and upload into VQD
- Manage the submission of shipping requests, collate appropriate documentation to support shipments and track R&D shipments of samples, CTM and other time sensitive materials
- Communicate with key business partners (internal and external) to ensure accurate and up to date information is maintained for program delivery
- Provide regular (weekly/biweekly) project communications with Clin Ops regarding key clinically meaningful data (CoA’s stability updates etc.)
- Liaise with SED Business Operations to ensure purchase orders and invoices are up to date.
Education
Bachelor's degree in a Science related field or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills, Abilities
- Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
- At least 1 year of experience working in a pharmaceutical or CRO industry position is required.
- At least 1 year of GMP experience is strongly preferred
- Critical thinking skills to identify and solve problems.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.
- Strong organizational skills in order to maintain a high level of productivity and setting priorities in order to complete assignments in a timely manner.
- Exhibits high initiative, strong drive and follow-through.
- Effective project management and organizational skills
- Good computer skills
- Strong attention to detail and problem solving skills
- Good written and verbal communication skills
- Ability to effectively conduct oral presentations
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Ability to maintain a high degree of confidentiality with clinical teams
- Ability to attain, maintain and apply a working knowledge of applicable procedural documents
- Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
Physical Requirements / Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below are the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
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