Job Overview:

Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Be responsible for end-to-end report management, including planning, authoring, and managing review, approval, and submission steps, per project scope and requirements. Apply safety domain knowledge and process expertise to manage deliverables of medium to high complexity. Ensure timely delivery of high-quality documents to internal customers and sponsors/clients. Coach, mentor, and provide shadowing opportunities and hands-on experience for the training and development of medical writers and junior associates. Support project management activities. 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 (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Report, ACOs, Addendum reports, as assigned.
• Author and review RMPs, adhoc reports, Benefit-Risk Evaluation reports, medical device reports.
• Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
• Conduct training for peers and junior team members, provide shadowing opportunities and hands-on experience.
• 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.
• Author/review manuscripts, abstracts, posters for conferences.
• Prepare medical information responses for HCPs.
• Perform/review signal detection activities. Participate in preparing signaling strategy signal/safety review meetings with clients and help gather safety data for signal evaluation by conducting searches in the safety database, published literature, external databases, etc.
• Author signal reports (ad hoc and periodic) and safety issue analysis reports.
• Act as a writing coach, devise training programs.
• Author/review SOPs/WIs/process documents or sections as applicable.
• Coordinate activities related to several types of report writing across a team of writers if applicable.
• 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 and co-ordination to get the required inputs.
• Get resolution on issues affecting project deliverables.
• Create and update labels e.g., Core Data Sheets, USPI, centralized SPC’s, Med Guides. Review and recommend label changes, author proposed label text and prepare supporting/justification document.
• Conduct literature searches and review for authoring several types of reports and routine surveillance. Review the articles selected by medical writers/junior staff, discuss conflicting review opinions with the safety physician.
• Perform 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.
• Create, maintain, and assume accountability for a culture of high customer service.
• 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.
• At least 4 years’ experience in the pharmaceutical industry, or at least 3 years of it in medical writing.

Experience (Minimum Required):

• 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 skills.
• Scientific or Clinical research experience desirable.
• Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

Preferred Qualifications Include:

• Advanced degree (e.g., PhD or Masters) preferred.

Physical Demands/Work Environment:

• Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.

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