Senior Safety Writer and Process Lead

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Perform allied activities like: Generation of line listings and summary tabulation, CFIs, CFCs.
Write and review various safety reports (or part of such reports) for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, bridging reports and other clinical documents as assigned.

Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
Author/ review RMPs, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, supporting document, Addendum reports etc.
Prepare medical information responses for HCPs.
Act as a writing coach.
Coordinate activities related to several types of report writing across a team of writers like schedule oversight, team allocations, communication with different teams for data etc., if applicable.
Liaise with client and act as a primary point of contact for all report writing activities.
Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training.
Assist in estimation of resource requirements and responding to RFPs as needed.
Internal and external (client) communication & co-ordination to get the required inputs.
Get resolution on issues affecting project deliverables.
Creating and updating labels, e.g., Core Data Sheets, USPI, centralized SPC’s, Med Guides.
Efficiency in conducting literature searches for authoring several types of reports. Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document.
Any additional activities as per the project requirement or manager’s discretion.
Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables.

Ensure compliance of operations with governing regulatory requirements.
And all other duties as needed or assigned.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

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