ICF Principal Medical Writer (FSP)
ICF Principal Medical Writer (FSP)
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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 be expanding our Medical Writing FSP Team in NA. We are looking for a Principal Medical Writer to be dedicated to a client in the FSP space; experience in Structured Content Authoring systems and automation to support delivery would be preferred. This role is dedicated to the end-to-end development and management of Master Informed Consent Forms (ICFs) for clinical trials. This role drives the implementation of ICF processes to improve quality reduce turnaround time and enhance compliance with global regulatory expectations. This role requires 5-10% travel including overnight and international travel to client sites.
Essential Functions:
Provides subject matter expertise and operational input into creating and finalizing ICFs using client templates processes and systems.
Coordinate and lead ICF Kick-off Meetings.
Attend and actively participate in study start up meetings related to ICF development and amendments.
Prepare study level Master ICFs from draft through final approval in collaboration with relevant stakeholders and file in TMF.
Support country and site-specific ICF reviews.
Coordinate ICF review and revisions following regulatory agency inquiries.
Manage ICF amendments and coordinate review approval and filing.
Coordinate reviews by functional stakeholders and ensure all pertinent reviews are completed prior to ICF approval.
Support updating centralized language libraries by identifying gaps and aiding in addressing them.
Review protocols and schedules of events to ensure accurate and compliant ICF content.
Support process improvement initiatives including creating onboarding materials and leading training sessions for ICF related topics.
Serve as a subject matter expert for ICF-related processes systems and workflows.
Support in follow-up to audit findings and CAPAsconcerning ICFs.
During periods of reduced workload on ICF tasks provide support with other study-related activities including TMF review and drafting of study plans
Education and Experience:
Bachelors degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification ; Life Sciences preferred.
Previous experience that provides the knowledge skills and abilities to perform the job (including 4 years in the pharmaceutical industry and/or clinical research organization and 2 years of experience in study start-up and ICF development).
Knowledge in global regulatory and compliance requirements for clinical research including but not limited to US CFR EU CTD and ICH GCP. Awareness of local country requirements is preferred.
Veeva experience preferred
Clinical background as an RN (Registered Nurse) is advantageous especially with direct involvement in patient-facing documentation and clinical trial operations
Knowledge Skills and Abilities:
Excellent organizational and program management skills
Proven skills in ICF authoring and management.
Extensive knowledge of regulatory guidelinesand drug development processes
Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders
Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards
Self-motivated and adaptable
Excellent judgment; high degree of independence in decision making and problem solving
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. As one team of 100000 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.
Required Experience:
Staff IC
Employment Type
Full-Time
