Thermo Fisher Scientific

Senior ICF Med Writing Project Manager/ICF Program Manager

Thermo Fisher Scientific • $100K — $130K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • BS/BA in a scientific discipline or advanced degree with relevant experience.
  • 5+ years of experience in clinical or medical writing project management.
  • Experience in the pharmaceutical/CRO industry is required.
  • Familiarity with Informed Consent Forms (ICF) preferred.
  • Proven project management skills, including budgeting and resource management.

Responsibilities

  • Develop project timelines, budgets, and contract modifications.
  • Collaborate with cross-functional teams to meet project deliverables.
  • Monitor and ensure achievement of final deliverables within timelines.
  • Evaluate risks to project quality and address as necessary.
  • Ensure compliance with quality processes for assigned programs.
  • Assist in business development through client presentations and proposals.
  • Mentor and provide training to junior ICF project managers.

Benefits

  • Support for health and well-being of employees.
  • Encouragement of a balanced work environment.
  • Access to professional development and training opportunities.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As an ICF Program Manager, you will lead patient-centric medical writing programs with a primary focus on Informed Consent Forms (ICFs), collaborating with internal and client teams while maintaining a high degree of client engagement and management. You will manage project timelines, budgets, and resources, ensuring the timely delivery and quality of complex programs of documents for internal and external clients. You will build client relationships and identify and resolve client management issues. Additionally, you will develop, monitor, and adapt project plans, client- and program-specific processes, timelines, and budgets/forecasting for assigned programs. You will also serve as a subject matter expert and mentor junior staff.

What You'll Do:
  • Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serve as liaison with other departments on contract modifications.
  • Collaborate with cross-functional team members as needed to meet the deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, and quality are maintained.
  • Ensure achievement of final deliverables within the contractual time period by preparing and monitoring timelines, providing status updates to the appropriate point of escalation, and regularly review projects using tracking and management tools.
  • Evaluate and appropriately escalate or resolve risks to project quality, budget, or timeline. Serve as a point of contact for risk escalation for programs managed by junior staff.
  • Ensure compliance with quality processes and requirements for assigned programs both within and between documents. Review and manage performance metrics for assigned programs, and support management of department-level performance metrics as needed.
  • 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
  • Provide training for ICF project managers on processes and technical aspects of program management
  • Support business development activities by partnering with senior management to secure new business through client presentations, proposal development, budget preparation, and contract negotiations.
  • Serve as a subject matter expert by providing guidance, mentoring, and training to ICF Project Managers on program management processes and best practices.


Education and Experience Requirements:
  • BS/BA (scientific discipline preferred) with at least 5 years relevant experience or an advanced degree with at least 3 years relevant experience.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • Experience in managing clinical or medical writing (or similar) projects required.
  • Experience working in the pharmaceutical/CRO industry required.
  • Experience in ICF content and customization (eg, Regulatory and/or plain language) 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.

Knowledge, Skills and Abilities:
  • Advanced project management skills, to include budgeting, forecasting, and resource management.
  • Expert planning and organizational skills to enable effective prioritization of workload.
  • Excellent interpersonal skills including problem solving, judgment, and decision-making skills; self-motivated and adaptable
  • Expert oral and written communication skills with internal and external stakeholders; advanced negotiation skills
  • In-depth knowledge of global, regional, national and other regulatory and document development guidelines relevant to patient-centric deliverables.
  • Excellent judgment; high degree of independence in decision making and problem solving
  • Capable of mentoring and leading junior level staff


Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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