Senior Safety Writer and Process Lead

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. Responsible for Coordinate activities related to several types of report writing across a team of writers. Perform various support activities such as tracking maintenance of metrics performing and documenting quality checks and training. Assist Medical Writers in preparing safety reports along with associated documents. 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:

• 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 and 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 SPCs 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 managers 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.

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 5-7 years experience in the pharmaceutical industry or at least 4 years in medical writing.
• Experience in drug discovery and pharmacovigilance is desirable.

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.
• Strong working knowledge of anatomy physiology disease states medical treatments and procedures.
• Thorough understanding of drug safety and management of benefit/risk assessment.

Preferred Qualifications Include:

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

Physical Demands/Work Environment:

• Client office as per assignment and/or home-based office.
• Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.

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