Principal Safety Writer

Job Overview:

Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables. Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables. Contribute to scientific publications and represent the company at scientific meetings and conferences. Work with the project management team to implement quality and process improvement initiatives. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

Summary of Responsibilities:

• Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned.
• Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions.
• Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level.
• Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities.
• Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports.
• Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed.
• Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback.
• Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs.
• Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable.
• Support project management activities such as maintenance of project schedules and tracking of metrics and compliance.
• Contribute to business development activities, including estimation of resource requirement and responding to RFPs.
• Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides.
• Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions.
• 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.
• Create, maintain, and assume accountability for a culture of high customer service.
• Perform any additional activities per project requirement or at the manager’s discretion upon completion of relevant training.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• Minimum of first degree in life sciences (or equivalent).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing.
• Excellent command of written and spoken English.
• Good written and verbal communication skills.
• Knowledge of MS Office.
• Good organizational and time management ability.
• Excellent interpersonal and leadership skills.
• Scientific or clinical research or medical writing experience desirable.
• Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.
• Excellent understanding of pharmaceutical product development cycle.
• Extensive knowledge of guidelines and regulations pertaining to regulatory submissions for US, EU and emerging markets.
• Ability to work independently, train and impart knowledge, coach, and mentor team members.
• Overall understanding of requirements for all types of regulatory documents.
• Help project managers/deliver managers in managing operations, performance, etc.

Preferred Qualifications Include:

• Advanced degree (e.g., PhD or Masters).
• Experience in drug discovery and pharmacovigilance is desirable.

Physical Demands/Work Environment:

• Office environment or remote.
• Available for travel 15% of the time including overnight stays as necessary consistent with project needs and office location.

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