Medical Writer (Consultant Level)
Biologics Consulting Group, Inc. seeks to hire a full-time Medical Writer. The position requires the successful candidate to write clinical documents for drug, biologic, and device products for human use across a range of therapeutic indications and clinical phases. The candidate will have excellent familiarity with the content and format and recent experience authoring clinical study reports, investigator brochures, protocols, PLLRs, and clinical sections of IND and marketing applications. Additionally, the candidate should be able to create and edit clinical documents associated FDA and EMA regulatory submissions, as well as research, write and edit clinical reports, summarize statistical data from clinical studies, write clinical study protocols, clinical plan outlines and sections of regulatory submission documents by applying therapeutic expertise and clinical drug development knowledge. Applicants will be considered that meet the qualifications below.
- Prepare, review, and edit clinical documents for regulatory submissions with minimum supervision
- Ensure that clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission.
- Advise on medical writing regulatory issues and submissions as detailed in current ICH, FDA, EMA and other applicable guidelines.
- In line with client requirements, devise and prepare medical writing deliverables for which little or no regulatory or other guidance is available, e.g., risk-benefit assessment reports.
- Interpret scientific information for inclusion in regulatory documents.
- Evaluate literature and other appropriate data sources for inclusion in regulatory documents
- Provide feedback to project managers on medical writing project timelines: coordinates and manages the tasks, roles, responsibilities, and timing of medical writing aspects of each project to facilitate document completion
- Contribute to clinical protocol development
- Coordinate on-time production of deliverables in a multi-disciplinary team
- Run effective teleconferences and meetings with clients
- Communicate effectively and clearly with those typically involved in the writing and review process including physicians, statisticians, data managers, and regulatory team members
- Writes, reviews, and edits scientific manuscripts, clinical study reports, plan outlines, protocols, documents for regulatory submissions (e.g. meeting packages, investigational new drug [INDs] applications, sections of marketing applications [NDA/MAA/CTD]), investigator brochures, posters, newsletters, orphan drug designations or other clinical and regulatory documents
- Interprets non-clinical and clinical data in the preparation of various technical reports
- Performs on-line literature searches
- Reviews all relevant documents and interacts with the functional leader and project manager to develop a thorough understanding of project timelines
- A bachelor’s degree or an advanced degree (M.S., Ph.D.) from an accredited institution in science or a health-related field, or equivalent international education
- Pharmaceutical or CRO industry experience developing pharmaceutical drugs for human use (e.g. pre-clinical science, medical-related writing, clinical trials management, monitoring, or as an investigator or sub-investigator for clinical trials)
- Current experience writing clinical sections of regulatory documents, clinical study reports, protocols, investigator brochures, orphan drug designations, poster presentations, and manuscripts for publication in a scientific journal writing guidelines in the host country
- Current experience leading the authoring of complex medical writing projects, including Integrated Safety Summaries/ Integrated Efficacy Summaries, package inserts, and risk management plans
- Excellent interpersonal, verbal and written communication skills
- Professional attitude
- Customer-focused approach to work.
- A flexible attitude with respect to work assignments and new learning
- Attention to detail.
- Excellent organizational skills
- Self-motivated to work consistently in a fast-paced, rapidly changing environment
- Ability to work independently
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
- Project management (planning and monitoring)
- Proficiency in MS Word, MS Excel and possess advanced word processing skills, the ability to understand and adapt to various IT systems
Applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-five years since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients internationally to address nonclinical, clinical, product development and manufacturing, and regulatory compliance challenges.
The cornerstone of this success is found in our team of consultants and professional services staff, comprising subject-matter experts with decades of industry and/or FDA experience. Biologics Consulting offers a great work environment, as well as a highly competitive salary and benefit package, including healthcare, 401k, and ESOP plans.
Biologics Consulting is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/reassignment, citizenship, pregnancy or maternity, veteran status, or any other status protected by applicable national, federal, state or local law.
To learn more about Biologics Consulting Group, Inc. please visit our website at: www.biologicsconsulting.com
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