Thermo Fisher Scientific jobs in Wilmington, NC - 41 jobs
Start Up Team Manager, FSP
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
**As the Start-up Team Manager at Thermo Fisher Scientific, you will play a pivotal role in site activation & manage complex site operations; ensure compliance with regulatory standards. In addition, this individual will be responsible for: supporting site recruitment and training efforts, and facilitate smooth collaboration between trial sites and internal teams to drive the success of clinical studies.**
**This individual is responsible for managing effective delivery of site activation within their assigned region(s). This role involves overseeing site activation according to timelines and quality standards, coordinating with others on a cross functional level, and managing technical and operational aspects.**
**Role: Start Up Team Manager**
**Location: Remote, US**
**Collaborate with team members to ensure effective site activation within assigned studies.**
**Coordinate SSU specialists across regions.**
**Ensure sites within their specific region are on track with the critical path site activation plan.**
**Serve as an escalation point for issues identified by SSU specialists, including regulatory and vendor setup issues.**
**Facilitate knowledge transfer across countries within regions.**
**Work with other Regional/Oversight Leads to resolve issues and ensure activation activities adhere to the agreed plan.**
**Oversee site activation according to timelines and quality standards within their specific region.**
**Assist with information flow between key stakeholders involved in site activation.**
**Oversee EC submission strategy and required documents (e.g., patient material, insurance certificates).**
**Provide quality checks for EC submission packages for both central and local ECs.**
**Manage technical and operational aspects, including feasibility, site selection, contracts coordination, and EC/RA submissions.**
**Ensure operational readiness for site activation in collaboration with CML (e.g., site binders, ancillary supplies, lab kits, training, system access).**
**Monitor regional study status, identify risks, and provide metrics to Study Start-up (SSU) Oversight Lead.**
**Maintain metrics and tracking tools for regional startup activity.**
**Perform risk identification and contingency planning, participate in risk escalation meetings as required, and collaborate with study team to address issues and implement solutions for countries and sites in region.**
**Manage country and site Informed Consent Form (ICF) timelines; review and approve country ICFs.**
**Provide performance feedback to People Manager and support staff learning opportunities.**
**Utilize problem-solving techniques in a changing environment.**
**Prepare for and participate in country level meetings.**
**Oversee and manage the clinical trial insurance local policy country set-up for region.**
**Oversee and manage amendment implementation as needed.**
**Skills and Abilities:**
**Effective collaboration with cross-functional teams.**
**Knowledge of key principles of cross-functional project management.**
**Strong organizational and multitasking skills.**
**Attention to detail.**
**Ability to identify and mitigate risks related to contractual deliverables.**
**Cross-cultural awareness and adaptability.**
**Comprehensive understanding of clinical research and development, including medical and therapeutic areas, phases, and terminology.**
**Ability to lead, liaise, and coordinate cross-functional project teams.**
**Knowledge of clinical development guidelines and directives.**
**Education and Experience:**
**Bachelor's Degree**
**Must have previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 5+ years**
**SSU experience has been in: CRO, Pharma organizations, highly preferred**
**In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.**
**Physical Requirements:**
**- Ability to work in an upright and /or stationary position for 6-8 hours per day.**
**- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.**
**- Frequent mobility required.**
**- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.**
**- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.**
**- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.**
**- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.**
**- Frequently interacts with others to obtain or relate information to diverse groups.**
**- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.**
**- Regular and consistent attendance.**
**Why Join Us?**
**When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference.**
**Apply today to help us deliver tomorrow's breakthrough.**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$64k-98k yearly est. 15d ago
Looking for a job?
Let Zippia find it for you.
Senior Patient Recruitment & Engagement Lead
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
PPD is revolutionizing patient recruitment. As the clinical research division of Thermo Fisher Scientific, PPD has launched Patient First, a group dedicated to enhancing the patient experience from the first click to the final visit. Using human-centered, digitally enabled solutions, Patient First optimizes patient recruitment and engagement, site operations, and quality data collection.
PPD is seeking a **Senior Patient Recruitment and Engagement Lead** to join our Patient Recruitment division. This role is responsible for leading multiple global studies and implementing strategy/driving delivery using recruitment and retention tools and site recruitment optimization tactics.
This is a home-based position for candidates in the US with global recruitment strategy and management experience and a comprehensive understanding of trial operations. The successful candidate will also have functional Lead experience within a team setting and customer management skills (including presentation experience).
**Functional Lead** :
+ Acts as a Functional Lead for recruitment and retention strategy and associated initiatives.
+ Communicates with the study team including the Project Manager, Clinical Team Managers and CRA's.
+ Ensure country and region-appropriate methods are used and requirements met.
+ Works to identify potential risks, develops contingency plans and escalates issues as appropriate.
+ Acts as Subject Matter Authority for patient recruitment and retention topics in all client communications.
+ Tracks metrics and builds progress reports on enrollment targets and provides updates.
**Strategy:**
+ Develops and implements patient recruitment and retention strategies.
+ Identifies potential barriers to recruitment and retention and develops risk mitigation plans.
+ Works with the client and the study team to identify strategic solutions for the specific protocol/patient population.
+ Provides support for proposals and bid defenses around recruitment lead activities.
**Third Party-Vendor Collaboration:**
+ Coordinates the quality and performance of third-party providers and addresses issues.
+ Works with PPD Finance contact to manage financial matters, ensures invoices are accurate and timely. Oversight for vendor budget.
+ Coordinates communication between providers, clients, and the internal study team.
**Patient Diversity:**
+ Collaborates with the Patient Population Science team to ensure that the Diversity Plan is reflected within the greater Study Recruitment and Retention Plan.
+ Ensures all client diversity requirements are considered during strategy design and monitored throughout enrollment.
+ Monitors patient diversity metrics throughout the study and reports progress to clients.
+ Patient Enrollment Optimization:
+ Partners with Enrollment Vendor Leads to avoid redundancy of vendor tasks and ensures compliance with the vendors designated activities.
+ Gathers feedback from study teams and clients to review vendor performance and provides feedback to the Vendor Relationship Lead.
**Education and Experience:**
+ Bachelor's degree or equivalent and relevant formal academic / vocational qualification
+ Previous patient recruitment management experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years)
+ In some cases an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills and Abilities:**
+ Excellent client-facing and interpersonal skills, with the ability to establish and maintain positive relationships.
+ Strong organizational and multitasking abilities, with capacity to handle multiple projects simultaneously and meet deadlines.
+ Analytical approach, with the ability to collect, analyze, and interpret data to drive informed decision-making.
+ Knowledge of healthcare regulations, patient privacy laws, and ethical considerations in patient recruitment.
+ Proficiency in project management tools and software.
At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:
+ 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 for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require as-needed travel (0-20%).
Location: Home-based US position. Relocation assistance is NOT provided.
*Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screening.
This is a salaried role ($100K - $125K USD) that will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Compensation will be initially discussed during the screening period, with actual compensation confirmed in writing at the time of offer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$100k-125k yearly 60d+ ago
Chemical Operator
Celanese 4.9
Wilmington, NC job
Process Expert (Chemical Operator) in production unit will be responsible for operating and troubleshooting equipment, assisting maintenance, and maintaining environment. Process Experts are required to learn all jobs in the unit including floor operations and control room, understand and follow all Site and Unit Safety procedures and protocols, and perform all functions necessary to chemical manufacturing.
Responsibilities:
Perpetuates a culture of safety, quality, reliability, and engagement with all colleagues, contractor, and guests in the unit.
Conduct routine checks on equipment and proactively report, mitigate, and solve emerging issues.
Operate field equipment (e.g., valves, pumps) to perform operations tasks per SOP.
Conduct Behavior Based Observations (BBO) and communicates HazRecs and Near Miss incidents.
Provide inputs to improve Standard Operating Procedures (SOPs) and Energy Isolation Plans (EIPs), provide updates and changes as needed.
Generates ideas and improvement projects.
Start up and shutdown of process equipment in a safe manner.
Attend training to improve and maintain production processes as required.
LOTO equipment and issues safe work permits to turn over equipment to maintenance for repairs and participate in return to service of equipment.
Housekeeping of area, participate in 5S.
Performs preliminary troubleshooting on equipment and process malfunctions and make first attempt repairs where appropriate.
Strictly follows all batch recipe sheets and instructions.
Maintains accurate records of all observations and results.
Accurately and thoroughly reports data via written (Logbook & SAP) to process leaders.
Ability to work 12 hour rotating shifts, including nights, weekends, holidays, and overtime.
Willing and able to work in inclement weather, climb structures and perform work at heights.
All candidates will be fit tested for respiratory protection, therefore, clean shaven will be required.
Qualifications:
High School diploma or equivalent
Mechanical and troubleshooting ability.
Manufacturing or industrial experience a plus
Effective communication skills both written and verbal to effectively interact with all levels of the organization.
Ability to manage multiple priorities to effectively manage the needs in a fast-paced work environment while ensuring quality work and accurate results.
Initiative, motivation, and self-discipline required to be successful in self-directed, collaborative work environment.
Computer skills/aptitude and or proficiency on PC based systems
Demonstrated ability to work as a contributing team member with a forward-thinking attitude and someone who encourages/engages others.
Celanese is a global leader in chemistry, producing specialty material solutions used across most major industries and consumer applications. Our businesses use our chemistry, technology and commercial expertise to create value for our customers, employees and shareholders. We support sustainability by responsibly managing the materials we create and growing our portfolio of sustainable products to meet customer and societal demand. We strive to make a positive impact in our communities and to foster inclusivity across our teams. Celanese Corporation employs more than 11,000 employees worldwide with 2024 net sales of $10.3 billion. For more information about Celanese Corporation and its product offerings, visit *****************
Celanese is an Equal Opportunity Employer. Celanese does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
$32k-37k yearly est. Auto-Apply 51d ago
2026 U.S Apprenticeship Program - Wilmington, DE
Dow Chemical 4.5
Wilmington, NC job
At Dow, we believe in putting people first and we're passionate about delivering integrity, respect and safety to our customers, our employees and the planet.
Our people are at the heart of our solutions. They reflect the communities we live in and the world where we do business. Their diversity is our strength. We're a community of relentless problem solvers that offers the daily opportunity to contribute with your perspective, transform industries and shape the future. Our purpose is simple - to deliver a sustainable future for the world through science and collaboration. If you're looking for a challenge and meaningful role, you're in the right place.
About You and this Role
We are seeking candidates for exciting and rewarding Process Technician Apprenticeship opportunities available at our facility in Wilmington, DE within the U.S. Apprenticeship Program.
As part of the U.S. Apprenticeship Program, Apprentices participate in a 2-3 year program offering hands-on work experience in our chemical plants while attending community college to earn a company-paid Associate's degree. During the program, Apprentices will be offered paid tuition, wages, and some benefits. Upon successful completion of the program, Apprentices will have earned an Associate's Degree in one of several technical disciplines. Apprentices will report to an Apprenticeship Program Leader who will support the Apprentice throughout the apprenticeship program. Apprentices who successfully complete the program will also be highly considered for a job within the company.
Individuals selected to fill an available Apprentice opening will be required to sign an offer letter that will commit them to working for Dow for 2 years upon being offered a full-time position.
The hourly rate of pay for this role will be at least $21.69. The exact pay rate will be communicated if you are chosen to receive an offer of employment. The hourly pay rate is set by the Company and is non-negotiable.
Expected hire date for these opportunities is June 8th, 2026; but it could go onto August 3rd, 2026 at the latest.
Responsibilities
Process Technician
Process Technicians operate equipment in assigned areas of the plant and perform operations related activities per the work process. They utilize chemical manufacturing knowledge and experience to operate and troubleshoot the plant in a safe and efficient manner.
Primary Responsibilities and Key Skills
Routine operation of basic control systems and devices to monitor levels, temperatures, pressures and flow rates, and transfer of products.
Controlling, monitoring and adjustment of all control systems and manually operated equipment.
Properly lifting hoses, bolt flanges and operate valves and similar equipment including the proper clearing and isolation of equipment.
Following operating discipline, procedures, and practices to ensure a safe and efficient operation of assigned duties.
Troubleshoot process, product quality, safety, and environmental problems, and identify equipment requiring maintenance.
How to perform maintenance and project work safely and efficiently.
Clearing and tagging equipment as required and issuing Safe Work Permits for maintenance and project work.
Performing all duties with a high degree of dedication to safety and environmental stewardship.
Qualifications
Educational Requirements
A minimum of a High School Diploma or GED is required.
Individuals who are currently enrolled in high school or college or have graduated or received a GED within the last two years will be required to provide official transcripts/GED scores prior to being invited to an onsite interview.
Must have completed Algebra or Technical Math and Science coursework in High School, per graduation requirements. Completion of Chemistry and / or Physics coursework in High School is preferred.
After an offer of employment, but prior to date of hire, must complete college entrance exams / assessments at the community college to be attended. Must not be required to take any remedial or transitional coursework.
If already enrolled in the degree program related to the field you applied for or have credits that would transfer toward it, individual must have no less than 2 full semesters remaining toward the applicable degree.
Preferred educational qualification: minimum GPA of 2.500 out of 4.000 if you are currently enrolled in high school or college OR you have graduated from high school or college or obtained a GED within the last 2 years.
Additional Requirements
Must be 18 years or older on or before your start date.
Must have a current, valid US driver's license or the ability to obtain prior to your start date. Please note that before being cleared to report to work, you will be required to successfully complete a Motor Vehicle Records check to verify the status of your driver's license.
Be able to work all applicable shifts on a rotating basis (including weekends & holidays) and work overtime, when needed.
A minimum requirement for this U.S. based position is the ability to work legally in the United States. No visa sponsorship/support is available for this position, including for any type of U.S. permanent residency (green card) process.
Preferred Skills
Active Learning: Demonstrate a strong willingness to learn and actively participate in training programs to gain a thorough understanding of manufacturing processes, safety protocols, and quality standards.
Time Management: Effectively manage time to ensure completion of tasks and upholding to production schedules, while maintaining high standards of quality and safety.
Enthusiasm for Learning: Proactively seek opportunities to learn new skills and improve existing ones, demonstrating initiative and a commitment to continuous improvement in manufacturing processes and techniques.
Troubleshooting (Problem-Solving): Skills in identifying and resolving processes, product quality, safety, and environmental issues.
Mechanical Aptitude: Ability in handling equipment and performing maintenance tasks.
Environment Health and Safety: Commitment to performing duties safely and with environmental responsibility.
Communication: Coordinating with co-workers and other team members effectively.
Physical Demands
Willing and able to meet physical demands of the job, with or without reasonable accommodations:
Lift 50 pounds, lift hoses, bolt flanges and operate valves and similar equipment routinely.
Climb ladders/stairs and work at heights.
Work in tight or closed-in spaces.
Must be able to wear and use personal protective equipment (PPE), including harnesses with a total weight capacity of 300lbs.
Work comfortably and safely at elevated heights. Candidates must be familiar with, or willing to undergo training in, the proper usage and maintenance of safety equipment to ensure safe movement and operations at heights.
Additional Notes: Relocation assistance is not provided.
About Dow
Dow (NYSE: DOW) is one of the world's leading materials science companies, serving customers in high-growth markets such as packaging, infrastructure, mobility and consumer applications. Our global breadth, asset integration and scale, focused innovation, leading business positions and commitment to sustainability enable us to achieve profitable growth and help deliver a sustainable future. We operate manufacturing sites in 30 countries and employ approximately 36,000 people. Dow delivered sales of approximately $43 billion in 2024. References to Dow or the Company mean Dow Inc. and its subsidiaries. Learn more about us and our ambition to be the most innovative, customer-centric, inclusive and sustainable materials science company in the world by visiting ************
As part of our dedication to inclusion, Dow is committed to equal opportunities in employment. We encourage every employee to bring their whole self to work each day to not only deliver more value, but also have a more fulfilling career. Further information regarding Dow's equal opportunities is available on ************
Dow is an Equal Employment Opportunity employer and is committed to providing opportunities without regard for race, color, religion, sex, including pregnancy, sexual orientation, or gender identity, national origin, age, disability and genetic information, including family medical history. We are also committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may call us at 1-833-My Dow HR ************** and select option 8.
$84k-152k yearly est. Auto-Apply 17d ago
NDE Level II, On-Site Inspection Technician
Celanese 4.9
Wilmington, NC job
The NDE Level II, On-Site Inspection Technician will primarily support the Wilmington, NC site and help with other regional sites as needed, through UT thickness and general visual inspections, examinations, and reporting. Scheduling completed through site management system with a goal of on-time completion of controllable examinations and accurate identification of potential issues. This role will also help support the site Authorized Inspectors through data collection, basic QA/QC tasks, and repair monitoring. The work environment is primarily open-air.
Responsibilities:
Perform various non-destructive examinations at the home site and supported facilities under the direction of the Authorized Inspector
Conduct UT thickness examinations both self-directed and directed on piping, tanks, and vessels.
Complete detailed reporting of findings timely.
Enter corrective action work notifications for applicable findings.
Help in performing PT examinations as needed.
Assist and learn technical matters involving company procedures and policies.
Key Competencies in this Position:
Adaptability
Collaboration
Communication
Driving for Results
Qualifications:
High School diploma or equivalent required. Some college preferred.
Preferred at least 2 years of industrial experience with storage tank, pressure vessel, and/or piping examinations, or other equivalent experience.
Level II UT thickness experience required. Other NDE experience preferred including PT, MT, VT.
Ability to travel around 5 weeks a year or more based on the business needs.
Knowledge of industry codes and standards, such as ASME, API, AWS, ASNT and ASTM, pertaining to various forms of non-destructive testing and inspection practices.
Ability to read and interpret technical drawings, P&ID's, isometrics, blueprints, and schematics.
Excellent communication skills to communicate technical information clearly and effectively to both technical and non-technical audiences.
Proof of classroom and OJT hours.
Experience with Microsoft Office Suite required. Data management systems (PSAIM, PCMS, etc.), PDF and CAD programs preferred.
Willingness and ability to work from heights, on scaffolding, and in confined spaces in all weather conditions.
Celanese is a global leader in chemistry, producing specialty material solutions used across most major industries and consumer applications. Our businesses use our chemistry, technology and commercial expertise to create value for our customers, employees and shareholders. We support sustainability by responsibly managing the materials we create and growing our portfolio of sustainable products to meet customer and societal demand. We strive to make a positive impact in our communities and to foster inclusivity across our teams. Celanese Corporation employs more than 11,000 employees worldwide with 2024 net sales of $10.3 billion. For more information about Celanese Corporation and its product offerings, visit *****************
Celanese is an Equal Opportunity Employer. Celanese does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
$30k-36k yearly est. Auto-Apply 9d ago
Production, Process Expert (Chemical Operator)
Celanese International Corporation 4.9
Wilmington, NC job
Process Expert (Chemical Operator) in production unit will be responsible for operating and troubleshooting equipment, assisting maintenance, and maintaining environment. Process Experts are required to learn all jobs in the unit including floor operations and control room, understand and follow all Site and Unit Safety procedures and protocols, and perform all functions necessary to chemical manufacturing.
Responsibilities:
Perpetuates a culture of safety, quality, reliability, and engagement with all colleagues, contractor, and guests in the unit.
Conduct routine checks on equipment and proactively report, mitigate, and solve emerging issues.
Operate field equipment (e.g., valves, pumps) to perform operations tasks per SOP.
Conduct Behavior Based Observations (BBO) and communicates HazRecs and Near Miss incidents.
Provide inputs to improve Standard Operating Procedures (SOPs) and Energy Isolation Plans (EIPs), provide updates and changes as needed.
Generates ideas and improvement projects.
Start up and shutdown of process equipment in a safe manner.
Attend training to improve and maintain production processes as required.
LOTO equipment and issues safe work permits to turn over equipment to maintenance for repairs and participate in return to service of equipment.
Housekeeping of area, participate in 5S.
Performs preliminary troubleshooting on equipment and process malfunctions and make first attempt repairs where appropriate.
Strictly follows all batch recipe sheets and instructions.
Maintains accurate records of all observations and results.
Accurately and thoroughly reports data via written (Logbook & SAP) to process leaders.
Ability to work 12 hour rotating shifts, including nights, weekends, holidays, and overtime.
Willing and able to work in inclement weather, climb structures and perform work at heights.
All candidates will be fit tested for respiratory protection, therefore, clean shaven will be required.
Qualifications:
High School diploma or equivalent
Mechanical and troubleshooting ability.
Manufacturing or industrial experience a plus
Effective communication skills both written and verbal to effectively interact with all levels of the organization.
Ability to manage multiple priorities to effectively manage the needs in a fast-paced work environment while ensuring quality work and accurate results.
Initiative, motivation, and self-discipline required to be successful in self-directed, collaborative work environment.
Computer skills/aptitude and or proficiency on PC based systems
Demonstrated ability to work as a contributing team member with a forward-thinking attitude and someone who encourages/engages others.
$70k-87k yearly est. Auto-Apply 51d ago
Program Manager Regulatory Medical Writing
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
Join us as a Program Manager within our Regulatory Medical Writing team where you will make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Regulatory Medical Writing Program Manager, you will lead client programs with high visibility among internal and client teams, often requiring a high degree of client engagement and management; manage client relationships and identify and resolve client management issues; manage and ensure the timely delivery and the quality of multiple program documents; develop, monitor, and adapt project plans, client and program-specific processes, timelines, and budgets/forecasting for programs. You will also serve as subject matter expert for assigned programs.
**What You'll Do:**
+ Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications.
+ Assist business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations.
+ Serve as point of contact for risk escalation for assigned programs. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.
+ Ensure compliance with quality processes and requirements for assigned programs both within and between documents within a project. Develops, reviews and manages performance metrics for assigned projects.
+ Provide training for medical writers on processes and technical aspects of program management.
+ May serve as backup medical writer. Duties could include researching, writing and editing clinical study reports and protocols, summarizing data from clinical studies, writing or providing input on complex clinical and scientific documents such as IBs, INDs, and MAAs, and providing senior review of project materials.
**Education and Experience Requirements:**
+ Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
+ Experience in managing and directing complex medical writing projects required
+ Experience working in the pharmaceutical/CRO industry preferred
+ Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills and Abilities:**
+ Solid program management skills to include budgeting, forecasting and resource management
+ Extensive knowledge of global, regional, national and other document development guidelines
+ In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
+ Excellent interpersonal, oral and written communication, and presentation skills
+ Excellent negotiation skills
+ Self-motivated and adaptable
+ Excellent judgment; high degree of independence in decision making and problem solving
+ Capable of mentoring and leading junior level staff
**Why Join Us?**
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$80k-108k yearly est. 15d ago
2nd Assistant
Newell Brands 4.3
Wilmington, NC job
Yankee Candle - Retail 2nd Assistant Manager Reports To: Store Manager Newell Brands is a leading $8.3B consumer products company with a portfolio of iconic brands such as Graco, Coleman, Oster, Rubbermaid and Sharpie, and 25,000 talented employees around the world. Our high-performance culture, unparalleled curiosity about the world around us, and talented people fuel our success. Our culture is enabled through our core values which guide all we do and how we win as One Newell. They are Integrity, Teamwork, Passion for Winning, Ownership & Leadership.
Job Overview
Support the Store Manager in executing the following roles and responsibilities to deliver an exceptional employee and guest experience and drive profitable top-line sales growth.
Responsibilities:
Team Experience:
* Assist in building a high-performing team that represents our Newell Brand Values: Passion for Winning, Integrity, Leadership, Ownership, and Teamwork.
* Contribute to effective onboarding and ongoing development of team members.
* Recognize and address positive and negative HR-related situations through performance management.
* Assist to motivate, inspire, and retain top talent.
* Provide coaching and foster a positive work environment.
Guest Experience:
* Contribute to creating a store environment focused on delivering an exceptional guest experience, driving sales results, and maintaining a safe, inviting shopping and working experience.
* Deliver an emotionally engaging guest experience by understanding guest needs, through product knowledge, and making emotional connections.
* Maximize sales potential by implementing company selling strategies, coaching to selling behaviors, and maximizing the Guest Sales Leader role.
* Drive guest loyalty through the Rewards Loyalty program, Key Performance Indicators (KPIs), Best Guest communication, and Grass Roots Marketing.
* Build lasting customer relationships to enhance loyalty.
* Maintain store appearance by implementing company visual standards through flawless execution of plan-o-grams, effective planning, visual maintenance, signage, and store cleanliness.
Operational Experience:
* Assist in analyzing the business, creating clear action plans that ensure effective execution of all operational activities.
* Assist in identifying root causes and help create effective action plans that drive results.
* Ensure clear, effective team communication that creates understanding and alignment.
* Support inventory management activities and control expenses.
* Incorporate safety and loss prevention measures into daily activities and follow company policies and Code of Ethics.
* Consistently achieve or exceed all Key Performance Indicator (KPI) goals through strategic planning, effective execution, and continuous performance improvement.
Qualifications:
* High School completion or equivalent GED.
* Proven experience in a retail management role (2 years preferred).
* Strong leadership and team management skills.
* Excellent communication and interpersonal abilities.
* Proficient in retail software and Microsoft Office.
* Strong analytical skills.
* Solution-oriented.
* Must be able to work in a fragrance-filled environment.
* Ability to work flexible hours, including weekends and holidays.
$27k-32k yearly est. 6d ago
Legal Entities Specialist III
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
As part of the Thermo Fisher Scientific team, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
**How Will You Make An Impact?**
The Legal Entities Specialist III plays a crucial role in the team responsible for managing legal entities. Key features of this US-based role are to provide corporate governance oversight for a portfolio of US subsidiaries.
The role will report to the Senior Manager, Legal Entities and will work closely with other members of the department. The candidate will also partner with other functions, including corporate tax, local tax and local finance. The role can be remote or hybrid, based in either Morrisville, North Carolina or Pittsburgh, Pennsylvania.
**What Will You Do?**
+ Lead and maintain company secretarial administrative matters for our US portfolio of entities
+ Assist in the production of annual meeting, including board and shareholder communications for a designated portfolio of legal entities within the US
+ Prepare, co-ordinate and supervise local regulatory filing submissions, including approvals
+ Maintain corporate directorship appointments, including preparation of associated documentation and reports
+ Collaborate with internal staff, business teams, legal advisors, auditors, treasury, tax, and external partners to support subsidiary formations, capital changes, ownership changes, dividend payments, reorganizations, and dissolutions, and other corporate governance matters in the US.
+ Provide support for ad-hoc projects as needed.
**We Are Looking For:**
Education/Experience
+ High school diploma, Associates or Bachelor's Degree preferred
+ Certification or certificate from an American Bar Association (ABA) approved program preferred
+ 4+ years experience as a corporate paralegal
+ Legal entities management experience is preferred
+ 1+ year experience working at a global company is preferred
+ Understanding of corporate governance requirements in North American jurisdictions
+ Knowledge of tax, legal and accounting functions
+ Previous exposure to Corporate Tax transactions and restructurings is preferred
+ Prior experience working with CSC Global online platform is helpful
+ Active commissioned notary is preferred
**Skills/Abilities**
+ Strong sense of ethics and integrity
+ Self-motivated and capable of working autonomously as well as collaboratively
+ Effective interpersonal and analytical skills
+ Attention to detail to ensure completeness and accuracy of work within established timelines
+ Strong dedication to taking ownership and consistently producing high-quality work
+ Collaborative style with experience working within a fast-paced matrixed environment
+ Able to effectively collaborate with teams across multiple time zones
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status **.**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$45k-85k yearly est. 60d+ ago
GCP Process Lead, FSP Clinical Compliance
Thermo Fisher Scientific 4.6
Thermo Fisher Scientific job in Wilmington, NC
As the GCP Compliance and Process Lead at Thermo Fisher Scientific, you will play a pivotal role in driving world-class quality and compliance strategies. This is an exceptionally outstanding opportunity to influence and improve our healthcare operations, ensuring flawless execution of regulatory standards. Your expertise will be crucial in determining and successfully implementing advanced quality assurance processes.
Role: GCP Process Lead, FSP Dedicated
Location: Remote, USA
Key Responsibilities
Facilitate and manage cross-functional teams' GCP inspection readiness activities throughout the study lifecycle.
Embed real-time inspection readiness strategies into daily operations, collaborating with study teams.
Provide just-in-time guidance on key operating model processes and required documentation, prioritizing real-time inspection readiness.
Manage and guide teams on inspection readiness planning, developing and maintaining readiness plans and tools.
Facilitate the development of key inspection deliverables, including functional presentations and study team preparation for audits.
Ensure high-quality deliverables for global studies by guiding adherence to operational processes and documentation.
Champion proactive prioritization of inspection readiness, focusing on GCP process excellence.
Engage with subject matter experts in inspection readiness activities and study-level risk assessments.
Coordinate and manage TMF performance and processes, ensuring compliance and inspection readiness.
Lead and participate in meetings for assigned projects, ensuring effective communication and addressing customer concerns.
Maintain project management documentation, including plans, timelines, and progress reports.
Coordinate activities to enable study team readiness for internal audits and regulatory inspections.
Manage functional teams during inspections, collaborate with SMEs, and ensure timely follow-up
Qualifications
Good understanding of clinical trial processes related to sponsor and CRO activities, including but not limited to sponsor oversight, issue management, site management, and clinical monitoring
Preferred experience with inspection preparation, including hands on regulatory inspection activities
Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field; with at least two years specifically supporting clinical Quality & Compliance
Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes
Proven awareness of sponsor oversight requirements and regulations
Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
Experience in problem solving, negotiations, and collaborative team building and other collaborators is required
Strong understanding of regulatory requirements within clinical trials, industry standards, and related documentation needs
Bachelor's degree preferred or commensurate with experience
Must be able to efficiently apply computer software programs like Microsoft Office for general use, project management, and presentations
Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
Domestic/international travel (5-20%) may be required
Inclusion and Collaboration
At Thermo Fisher Scientific, we value diverse experiences, backgrounds, and perspectives. Our inclusive culture fosters collaboration and innovation, empowering each team member to contribute to our mission of advancing science and healthcare.
$86k-109k yearly est. Auto-Apply 60d+ ago
Medical Writing Manager (FSP)
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
At Thermo Fisher Scientific, you will 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.
**Summarized Purpose:**
We are excited to announce that we are looking for an FSP Medical Writing Manager in the United States! Are you an experienced Medical Writer ready to take the next step in your career? Do you thrive leading teams and driving excellence in clinical documentation? If so, we want to hear from you.
As a Medical Writing Manager, you will lead a team of talented Medical Writers, and blend scientific expertise, operational leadership, and strategic insight to guide high-visibility projects and shape best-in-class medical writing practices.
This role is perfect for a seasoned writer with leadership experience who's ready to elevate both people and process.
**What You'll Do**
Lead & Develop a High-Performing Team
· Manage, mentor, and develop Medical Writers to ensure exceptional performance and continuous growth.
· Oversee workload distribution, resource planning, and project assignments.
· Conduct regular 1:1s, performance reviews, and coaching conversations.
Drive Quality & Delivery Excellence
· Supervise and review the preparation of a wide range of medical writing deliverables.
· Ensure projects are completed on time and to the highest scientific and regulatory standards.
· Serve as a senior reviewer and departmental expert for study design, adverse event reporting, and interpretation of statistical data.
· Stay current with ICH, FDA, and global regulatory guidance.
Represent the Department Externally
· Deliver compelling capabilities presentations to prospective clients.
· Collaborate with Business Development and Contracts teams to support bids, budgets, and proposals.
Shape Medical Writing Strategy & Processes
· Contribute to the development, evaluation, and improvement of SOPs and work practices.
· Lead or support internal training programs to ensure new and existing staff are well-equipped for success.
**What You Bring**
· Bachelor's degree in a life science field (advanced degree-PharmD, PhD, MSc-preferred).
· 5+ years of relevant regulatory writing experience, including at least 2 years in medical writing within pharma/CRO and 1+ year of leadership responsibility.
· Exceptional writing, editorial, and data interpretation skills.
· Strong project management ability-forecasting, timelines, resource allocation.
· Excellent communication and presentation skills, especially in client-facing settings.
· Ability to manage complexity, multitask, and work in a fast-paced environment.
**What We Offer:**
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain five reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$108k-178k yearly est. 10d ago
Staff Software Engineer
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
**Staff Software Engineer (Angular / C#.NET / SQL / MongoDB / Cloud Services)** The **Staff Software Engineer** will be responsible for architecting, developing, and maintaining modern, scalable web applications using **Angular** for the front end and **C#.NET** for the back end. This role includes constructing reliable integrations with SQL Server, MongoDB, and cloud platforms like Azure or AWS to support critical business and internal applications.
This position calls for a robust full-stack development background, a comprehensive grasp of software building principles, and the skill to lead technical initiatives while collaborating closely with multi-functional teams.
**Key Responsibilities**
+ Manage the development, creation, and maintenance of web applications with Angular, C#.NET, and ASP.NET Core.
+ Architect and build **RESTful APIs** and **microservices** to support scalable and secure application development.
+ Develop and improve databases on SQL Server and MongoDB, ensuring data integrity, performance, and security.
+ Develop and lead **cloud-based deployments** using platforms such as **Azure App Services** , **Azure Functions** , or **AWS Lambda** .
+ Offer technical guidance and mentorship to junior developers, implementing guidelines in coding, testing, and deployment.
+ Collaborate with product owners, QA, and DevOps teams to define requirements, work you're doing, and timelines.
+ Integrate third-party and internal APIs and ensure seamless data flow between systems.
+ Address and resolve complex technical issues across the application stack.
+ Implement CI/CD pipelines and automated testing to streamline deployment processes.
+ Keep user documentation current, covering architecture diagrams, updates to SRS/SDS, and deployment procedures.
**Qualifications**
+ Bachelor's degree in Computer Science, Engineering, or related field.
+ **5+ years of hands-on experience** in web application development using **C#.NET** and **Angular** .
+ Strong front-end experience with **Angular (v10 or newer)** , **TypeScript** , **HTML5** , and **CSS3** .
+ Deep understanding of **ASP.NET Core** , **Entity Framework** , and **REST API** development.
+ Solid experience working with both **SQL Server** and **MongoDB** databases (data modeling, queries, and performance tuning).
+ Shown experience deploying and maintaining applications in **cloud environments** (Azure or AWS).
+ Proficiency in leading continuous integration/continuous deployment workflows, Git, Azure DevOps, or equivalent platforms.
+ Strong understanding of **object-oriented programming** , **SOLID principles** , and **software architecture guidelines** .
+ Excellent communication, problem-solving, and leadership skills.
+ Must be legally authorized to work in the United States without sponsorship.
**Preferred Qualifications**
+ Experience with **.NET 6+** , **microservices architecture** , and **containerization (Docker/Kubernetes)** .
+ Knowledge of **serverless computing** , **API gateways** , and **cloud monitoring tools** .
+ Experience with **Agile/Scrum** methodologies.
+ Prior experience in **manufacturing** , **laboratory** , or **regulated environments** is a plus.
**Compensation and Benefits**
The salary range estimated for this position based in Indiana is $93,800.00-$140,675.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
POSITION SUMMARY
As a Director, Manufacturing Engineering Sterile Pharmacuetial Equipment, you will engage with and support the 3 steriles manufacturing sites in North America. We are seeking a professional with in-depth knowledge of sterile manufacturing equipment. In this role you will provide recommendations on equipment requirements, engage on trouble shoot equipment, and lead new equipment start ups. This role supports the commercial operations including root cause analysis and problem solving on machine issues on the sites. You will remove roadblocks and drive intensity to the operations, maintenance activities, and capital project. You will work alongside the sites to guarantee capital project execution, establishment and oversight for all major investments to align with the business plans. This role will be a key partner and collaborator with the DPD- EU team growing consistency in the sterile network. The position involves working closely with Quality, IT, Supply Chain, and Sustainability teams to guarantee that the Capital, Engineering, and Maintenance teams follow policies, master planning, shutdown planning, and fulfill company commitments. This is an outstanding opportunity to create an impact with Thermo Fisher Scientific.
**KEY RESPONSIBILITIES**
+ Technical domain authority on Sterile Equipment
+ Equipment Lifecycle Planning
+ Maintenance Excellence Program
+ Data and information exchange
+ Capital project governance
+ New Asset Start up and Readiness
**QUALIFICATIONS AND REQUIREMENTS**
Education
+ Bachelors degree in Engineering or related field
+ Masters Degree is desirable
Experience:
+ 10+ years experience in Engineering with a consistent track record
+ Specific knowledge and experience with Sterile Pharmaceutical manufacturing equipment
Knowledge, Skills, Abilities:
+ Knowledge of Isolators, Fill Finish Equipment, Compounding Equipment, Lyophilizers, Automatic visual inspection equipment and ancillary equipment.
+ Understanding Auto-Injector equipment is valuable
+ Knowledge of Pharmacuetial regulatory requirements
+ Outstanding leadership and management skills.
+ Ability to implement global standards.
+ Strong analytical and problem-solving skills.
+ Experience in leading teams and/or initiatives is a plus
+ Self-directed with strong partner development skills.
+ Ability to lead and influence in a matrix and global environment.
+ Consistent in delivering results.
**Compensation and Benefits**
The salary range estimated for this position based in North Carolina is $160,100.00-$225,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$160.1k-225k yearly 31d ago
FSP Country Approval Specialist
Thermo Fisher Scientific 4.6
Thermo Fisher Scientific job in Wilmington, NC
Join Us as a Country Approval Specialist (Site Activation Specialist)- Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.
What You'll Do:
• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPD's target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves
Compensation and Benefits
The salary range estimated for this position based in North Carolina is $73,000.00-$83,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
$73k-83k yearly Auto-Apply 2d ago
Digital Product Portfolio Head
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
The PPD clinical research business of Thermo Fisher Scientific is a leading provider of global CRO solutions. We provide comprehensive drug development, laboratory and lifecycle services to customers across pharmaceutical, biotechnology, medical device, academic and government entities. By harnessing innovative technology and expertise, we work to empower our customers to bring therapies to market, faster.
We have an exciting new opening for a **Digital Product Portfolio Head** (known internally as Sr Director, Digital Product) to own the strategy, prioritization, and value realization for an end-to-end digital domain, specifically clinical trial execution, supporting and building new products that spans study start to final regulatory delivery. This role is responsible for leading Product Managers and UX Designers- and partnering in a matrix with Engineering, Data Science, and Quality- and will incubate internal products and solutions, quantify ROI through measurable efficiency gains, and guide readiness for future external monetization.
Reporting to the VP/Head of Digital Products, you are accountable for domain vision, business-case development, roadmap execution, user outcomes, and regulatory compliance (21 CFR Part 11, ICH-GCP, GDPR, HIPAA).
This is a home-based role (or hybrid) for candidates in the US (East Coast preferred). Travel is estimated up to 25% for site visits, customer meetings, and team onboarding across Europe, India, and North America.
**Key Responsibilities:**
**Strategic Roadmap & Vision**
+ Craft a 3-year vision that accelerates trial timelines and differentiates PPD.
+ Translate vision into rolling 12-month roadmaps aligned to corporate OKRs and business objectives.
+ Continuously monitor industry trends, competitor strategies, and technological advancements to ensure the product portfolio remains competitive and innovative.
**Business-Case & ROI Development**
+ Build investment dossiers (TAM, cost-benefit, payback, NPV) for new initiatives.
+ Establish value-tracking metrics (cycle-time reduction, FTE hours saved, quality KPIs) and partner with Finance to baseline and report realized gains.
+ Develop comprehensive financial models with partnership from finance and operations to support strategic decisions and present these models to senior leadership and stakeholders.
**Product Life-Cycle & Delivery Oversight**
+ Lead discovery, prioritization, backlog refinement, and acceptance criteria.
+ Co-own sprint cadence and release readiness with Engineering Leaders.
+ Ensure robust product lifecycle management processes are in place, from ideation through to product retirement.
**People & Org Leadership**
+ Line-manage Product Managers / Senior PMs and UX Leads.
+ Coach craft mastery, career paths, and a user-centric, data-driven culture across US, UK, Eastern Europe, and India hubs.
+ Foster a collaborative and inclusive team environment that encourages innovation and continuous improvement.
**Stakeholder & Customer Engagement**
+ Serve as a liaison to study teams, investigators, sponsors, and regulatory/quality partners; champion voice-of-customer and usability.
+ Develop and maintain strong relationships with key stakeholders to ensure alignment and support for product initiatives.
**Governance & Compliance**
+ Own validation strategy (CSV, Part 11), privacy impact assessments, and security posture with Quality, Security, and Engineering
Qualified candidates will have a demonstrated record of developing business cases and ROI models for digital initiatives (≥$10M) and steering them through funding gates. Experience partnering with engineering organizations to deliver complex, regulated products will be critical, as well as a deep understanding of clinical-trial operations (recruitment, start-up, clinical operations, data management, RBM, safety) and associated regulations.
**Product-Management Leadership Competencies:**
**Strategic Product Visioning:** Turn ambiguous goals into a crisp 3-year vision and phased roadmap balancing internal efficiency and future market revenue.
**Portfolio Prioritization & Resource Allocation:** Apply RICE/WSJF at portfolio scale; reallocate team capacity based on live ROI and risk data.
**User-Centric Discovery & Validation:** Lead problem interviews, journey mapping, rapid MVP/A-B experiments to de-risk before heavy build.
**Data-Driven Decision-Making:** Define North-Star & leading metrics; build self-serve dashboards so squads can course-correct.
**Product Storytelling & Influence** : Craft narratives linking clinical-outcome gains to business value; secure funding via clear storytelling.
**Cross-Functional Leadership (no authority):** Align Engineering, QA, and Compliance on priorities through shared OKRs; resolve conflicts by influence.
**Coaching & Talent Development** : Mentor PMs, run product leadership meetings, drive craft reviews and growth culture.
**Operational Excellence / Product Ops** : Implement intake triage, release readiness, KPI hygiene; partner with Engineering on cycle-time tracking.
**Regulated-Market Lifecycle** : Integrate Design Controls, CSV, privacy-by-design from ideation onward; balance agility with validation.
**Financial & Business-Case Mastery:** Build TAM, NPV, payback models; translates cost-avoidance into CFO-grade ROI narratives.
**Go-to-Market & Change Management:** Shape launch and adoption plans; lead internal change-management playbooks for study teams.
**Innovation Scouting** : Inject emerging tech (AI/ML, decentralised trials) into roadmap through structured discovery.
**Required Qualifications:**
+ Bachelor's in Life Sciences, Computer Science, Engineering, or related; MBA / MS preferred.
+ Previous experience in product or business management leadership in software/SaaS that provides the knowledge, skills, and abilities to perform the job (comparable to 15 years' experience).
+ 5+ years' experience leading staff
+ In some cases, an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
**Preferred Qualifications**
+ Leadership experience in a CRO, eClinical tech provider, or digital-health start-up.
+ Exposure to AI/ML in commercial software.
+ Pragmatic Institute PMC, Agile/Scrum, SAFe or equivalent certification.
+ Published thought leadership on digital clinical-trial innovation.
**Knowledge, Skills and Abilities:**
+ Proven ability to lead and influence engineers, designers, analysts, and stakeholders.
+ Experience building intuitive user experiences at scale.
+ Experience in AI/ML
+ Familiarity with agile tools (e.g., Jira, Aha!, Azure DevOps).
+ Demonstrated experience managing detailed product execution within large, matrixed organizations.
+ Skilled at managing up and aligning with stakeholders.
+ Skilled at executive-level storytelling, roadmaps and tradeoff discussions.
+ Exceptional skill in translating complex business requirements into intuitive, impactful software features that exceed customer expectations.
+ Deep understanding of clinical trial processes, clinical data management, and leveraging AI technologies to address data complexities.
+ Proven ability to leverage user insights and data analytics to drive feature development and continuous improvement.
+ Outstanding English communication and stakeholder management abilities, capable of clearly articulating detailed product requirements and vision.
**Location:** United States. Relocation assistance is NOT provided.
*Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screening.
At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:
+ 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 for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ International travel up to 25%
The annual salary range estimated for this position is $180,000- $275,000 USD. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
**Compensation and Benefits**
The salary range estimated for this position based in North Carolina is $183,900.00-$275,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$90k-119k yearly est. 60d+ ago
Clinical Study Manager, FSP - IVD Experience Required
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
REMOTE: We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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.
We have a functional service provider solution, which is a unique partnership that allows our customers to leverage 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.
**Summarized Purpose:**
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.
**Essential Functions**
+ Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
+ Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
+ Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
+ Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
+ Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
+ Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
+ May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
+ Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
+ In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities.
**Job Complexity:** Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
**Job Knowledge:** Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.
Supervision Received
Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
**Business Relationships:** Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.
**Qualifications:**
**Education and Experience:**
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
_In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._
**Knowledge, Skills and Abilities:**
+ Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
+ Strong In Vitro Diagnostic Devices Regulations (IVDR), and ISO20916
+ Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
+ Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization
+ Solid understanding of change management principles
+ Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
+ Strong judgment, decision making, escalation, and risk management skills
+ Effective oral and written communication skills, including English language proficiency
+ Capable of evaluating own and team members workload against project budget and adjust resources accordingly
+ Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
+ Strong attention to detail
+ In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
+ Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
+ Capable of independently managing clinical only studies
Management Role:
No management responsibility
Working Conditions and Environment:
· Work is performed in an office environment with exposure to electrical office equipment.
· Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements:
· Frequently stationary for 6-8 hours per day.
· Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
· Frequent mobility required.
· Occasional crouching, stooping, bending and twisting of upper body and neck.
· Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
· Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
· Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
· Frequently interacts with others to obtain or relate information to diverse groups.
· Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
· Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
· Regular and consistent attendance.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$71k-95k yearly est. 6d ago
PSA Manager
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
Thermo Fisher Scientific is seeking a PSA Solution Manager to administer and enhance our Professional Services Automation (PSA) platform, Certinia. In this role, you will support key services operations such as forecasting, utilization visibility, data governance, reporting design, and process optimization. You will also lead the evaluation of future PSA solutions and help define our long-term PSA strategy.
This position plays an important role in enabling our teams to deliver exceptional customer outcomes and supports our Mission-to enable our customers to make the world healthier, cleaner, and safer.
Location: Madrid, Spain; Budapest, Hungary; Durham, North Carolina; Columbus, Ohio; or Pittsburgh, PA
Responsibilities
· Administer and optimize the Certinia PSA platform, ensuring stability, data quality, and usability.
· Design and refine PSA processes across forecasting, utilization tracking, project and resource data, and time & expense workflows.
· Partner with analytics teams to define dashboards, reporting requirements, and data structures that support business insights.
· Manage PSA enhancements, configuration changes, and roadmap planning in collaboration with IT and business stakeholders.
· Lead the evaluation of future PSA solutions, including requirements gathering, vendor assessment, and future-state process design.
· Support planning and scoping activities related to potential PSA migration efforts.
· Provide user support, documentation, training materials, and change-management guidance.
· Collaborate with global Services, Finance, Operations, and IT teams to ensure alignment and adoption.
Requirements
· Bachelors degree with 5-10+ years of experience in PSA administration, professional services operations, or business systems roles.
· Experience with PSA platforms (Certinia, SAP PSA, etc.).
· Strong understanding of services processes: forecasting, utilization, resource planning, project structure, and time & expense.
· Advanced proficiency in Excel, data analysis, and reporting.
· Experience defining business requirements, evaluating solutions, and designing future-state processes.
· Ability to manage system enhancements and coordinate with IT and cross-functional teams.
· Excellent communication and stakeholder management skills.
Knowledge, Skills, and Abilities
· Technical Expertise: Proficiency in Salesforce CRM, Certinia/FinancialForce PSA, Jira, PowerBI. Background supporting enterprise software evaluation or migration initiatives
· Analytical Mindset: Skilled at turning complex datasets into actionable insights that support revenue growth.
· Project Management: Strong organizational and prioritization skills, with the ability to manage multiple complex initiatives simultaneously.
· Communication: Excellent stakeholder management skills; able to convey complex information clearly to both technical and business audiences.
· Problem-Solving: Demonstrated ability to identify gaps in processes and systems, and to implement scalable solutions.
· Global Orientation: Comfortable working with teams across geographies and time zones, ensuring consistent revenue operations practices worldwide.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$78k-109k yearly est. 12d ago
Medical Writer - Medical Information
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
The Medical Writer will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
**Job Responsibilities:**
+ Develops and updates standard medical response documents, custom response documents, frequentlyasked questions, and Academy of Managed Care Pharmacy formulary dossiers, specific to the peri- andpost-approval phases of the product lifecycle.
+ Researches and responds to escalated medical information inquiries from healthcare providers.
+ Conducts literature searches for standard response documents utilizing secondary databases.
+ Utilizing professional judgment, integrates pertinent clinical data into standard response documentswith clear, concise, accurate and balanced medical writing following organizational, client, andregulatory guidelines.
+ Participates as required in project launch meetings, review meetings, and project team meetings, servingas a liaison for communication with the client.
+ Collaborates and effectively communicates with internal and external client contacts to provide highquality medical information writing deliverables in a timely manner and within budget.
**E** **d** **u** **c** **a** **t** **ion** **a** **n** **d** **E** **x** **p** **e** **r** **i** **e** **n** **c** **e** **:**
+ PharmD
+ Experience with Medical Information (equivalent to 2+ years)
+ Previous experience that provides the knowledge, skillsand abilities to perform the job (comparable to 2+ years)
+ Experience working in the pharmaceutical/CRO industry preferred
**K** **n** **o** **w** **l** **e** **dg** **e** **,** **S** **k** **i** **l** **ls,** **a** **n** **d** **A** **b** **i** **l** **i** **t** **i** **e** **s** **:**
+ Solid medical writing skills, including grammatical, editorial and proofreading skills
+ Ability to interpret and present complex data accurately and concisely
+ Effective administrative, organizational and planning skills; attention to detail and quality
+ Ability to work on own initiative and effectively within a team
+ Effective oral and written communication skills
+ Great judgment and decision-making skills
+ Good computer skills and skilled with client templates; good knowledge of documentmanagement systems and other relevant applications (e.g. Excel, Outlook)
_Thermo Fisher 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 is listed 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 for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$74k-96k yearly est. 15d ago
Patient Recruitment & Retention Strategy Lead - FSP
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
This role is part of the Site and Patient Engagement team within Trial Operations at the client. The Patient Recruitment & Retention Strategy Lead encompasses strategic leadership and oversight of patient recruitment efforts across multiple clinical trials/indications across the client. This role will work with the global clinical team and leaders to understand patient recruitment needs at a disease and study level and developing appropriate solutions. The role is crucial in ensuring the successful recruitment and retention of participants in clinical trials. Expected travel: 10-15%.
**ROLES AND RESPONSIBILITIES**
+ **Strategic Planning:** Develop and execute comprehensive patient recruitment strategies with the objectives and timelines of each clinical trial. This involves analyzing study protocols, understanding the target patient populations and identifying effective recruitment channels. Partners with study leaders and cross-functional partners on the diversity strategy and actively contributes to the indication-specific diversity plan.
+ **Stakeholder Collaboration:** Collaborate with Indication Development Teams and cross-functional partners, including Trial Operations, medical affairs, regulatory affairs, global patient advocacy, and Global Sourcing & Vendor Alliance Management (GloSAM). Ensure alignment of recruitment strategies with study protocols and regulatory requirements. Provide coaching and mentoring to other team members Provide input to procedures/SOPs/Wis and related documents. Participate in workstreams.
+ **Budget Management:** Manage recruitment budgets for multiple clinical trials in coordination with the appropriate Clinical Operations Development Lead (CODL).
+ **Vendor Management** : Oversee relationships with external vendors and recruitment agencies involved in patient outreach, screening and enrollment activities. Evaluate vendor performance. This includes the review and coordination of all approvals of patient recruitment materials. Collaborate with GloSAM to negotiate contracts and Quality team to ensure compliance.
+ **Data Analysis and Metrics Reporting:** Utilize data analytics tools to track recruitment metrics, monitor progress and identify trends. Implement quantitative methods for measuring the impact of specific recruitment tactics. Leverage metrics to inform recruitment strategy across IDTs and implement continuous improvement Collaborate with data science partners on how we can leverage data science approaches and data sources for identifying geographic regions of interest and site and patient identification to optimize recruitment strategy. Generate regular reports for senior management and study teams providing insights and recommendations for optimization.
+ **Ethical and Regulatory Compliance:** Ensure that all recruitment activities adhere to ethical standards, regulatory requirements and Good clinical Practice (GCP) guidelines.
+ **Continuous Improvement:** Implement process improvements and best practices to enhance recruitment efficiency and effectiveness. Ensure best practices and lessons learned are shared across trials/indications/assets. Stay abreast of industry trends, emerging technologies and innovative recruitment solutions.
+ **Patient Engagement and Retention** : Develop strategies that engage patients throughout the clinical trial lifecycle, fostering a positive experience and positioning the client as Sponsor of Choice for clinical trial participation.
+ **Risk Management:** Identify potential risks and challenges related to patient recruitment and collaborate with CRO/vendor to develop contingency plans to ensure study timelines are met.
**SKILLS AND COMPETENCIES**
+ Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial
+ Ability to work with vendors and external stakeholders with timely communications
+ Highly organized with a positive attitude; Works well through change and shifting priorities
+ Strong planning, organizational and project management skills
+ Ability to communicate effectively and professionally
**EDUCATION, EXPERIENCE AND QUALIFICATIONS**
+ Bachelor's degree in a scientific, marketing or communications discipline
+ 10+ years of experience
+ Relevant industry experience (pharma, biotech, CRO required
+ Experience implementing or overseeing patient recruitment strategy
+ Experience leading implementation and strategy development teams and working in a global environment
+ Auto-immune and/or oncology clinical trial background is a plus
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$70k-89k yearly est. 60d+ ago
Sr. Manager/Associate Director, Global Market Development, Analytical Services Division
Thermofisher Scientific 4.6
Thermofisher Scientific job in Wilmington, NC
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
As **Senior Manager (or Associate Director), Market Development,** you'll play a pivotal role in bringing our innovative scientific Analytical Services Division solutions to market-designing global marketing strategies that spark demand, fuel growth, and connect breakthrough products with customers who are transforming science and healthcare worldwide.
In this highly visible role, you will:
+ Lead the creation and execution of integrated, data-driven marketing programs for our ASD group across a dynamic, global matrix organization.
+ Partner closely with cross-functional teams, translate market insights into compelling go-to-market strategies, identify new growth opportunities, and deliver campaigns that drive measurable impact and revenue.
+ Guide diverse teams, influencing senior stakeholders, and building strong partnerships across the business.
Your work will directly shape our market presence while advancing our mission to enable our customers to make the world healthier, cleaner, and safer.
If you're energized by global impact, strategic ownership, and the chance to influence how cutting-edge science reaches the world, this is your opportunity.
**EDUCATION AND EXPERIENC** E:
+ Bachelor's degree in marketing, Business, Life Sciences, or a related field with 8+ years of marketing experience or Advanced degree with 6+ years of experience.
+ Previous experience developing and executing successful product launches and go-to-market strategies that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years' experience)
+ 3+ years of people management experience, with a proven ability to lead, develop, and inspire teams
+ In some cases, an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
**KNOWLEDGE, SKILLS AND ABILITIES** :
+ Deep understanding of core marketing fundamentals, including market segmentation, demand generation, positioning, and integrated campaign development
+ Strong analytical and problem-solving skills, with the ability to translate market data and performance metrics into actionable insights
+ Proven success in digital marketing across multiple channels, including web, social media, email, and search
+ Ability to engage and influence stakeholders
+ Matrix organization navigation
Location: Remote US or UK. Relocation assistance is NOT provided.
*Must be legally authorized to work in your country of residence without sponsorship.
*Must be able to pass a comprehensive background check. In the US, this includes a drug screening.
The annual salary range estimated for this position is $115,000- $135,000 USD in North Carolina. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:
+ 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 for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require 10-25% travel
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.