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Medical Writer II/III (aggregate report experience required)

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  • Job
    Full-time
    Mid & Senior Level
  • Science
    Healthcare

Requirements

  • Previous experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing
  • Pharmacist or MD, life science MD
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail
  • Ability to effectively train and mentor Associate Medical Writers
  • Advanced knowledge of English

Responsibilities

  • Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports, risk management plans and other documents needed throughout the product’s life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards
  • Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
  • Support in all pharmacovigilance operations associated with medical writing
  • Continuous self-education in all aspects associated with medical writing

FAQs

What is the job title for this position?

The job title is Medical Writer II/III.

Is aggregate report experience required for this role?

Yes, aggregate report experience is required.

What qualifications are needed for this position?

Candidates should have previous experience in pharmacovigilance medical writing, including PBRERs, DSURs, and RMPs writing, and possess a degree as a pharmacist, MD, or life science MD.

What are the key responsibilities of the Medical Writer II/III?

Key responsibilities include independent authoring, editing, and reviewing regulatory/clinical documents, participation in training, maintaining quality system documents, supporting pharmacovigilance operations, and self-education in medical writing.

What language proficiency is required for this position?

Advanced knowledge of English is required.

Is there an opportunity for career development in this role?

Yes, there are training and career development opportunities available internally.

What kind of working environment can I expect?

You can expect a friendly, supportive working environment with an emphasis on personal and professional growth.

Will I have the opportunity to work internationally?

Yes, you will have the opportunity to work with colleagues based all over the world, with English as the company language.

Does PrimeVigilance prioritize diversity and inclusion?

Yes, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace.

What are some of the core values of PrimeVigilance?

The core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships.

What benefits do employees receive?

Employees receive training and career development opportunities, strong emphasis on personal and professional growth, and the chance to work in a supportive environment.

Is mentoring available in this role?

Yes, the role includes the ability to effectively train and mentor Associate Medical Writers.

What does PrimeVigilance focus on in terms of employee well-being?

PrimeVigilance acknowledges that a healthy work-life balance is critical for employee satisfaction and well-being.

How long has PrimeVigilance been established?

PrimeVigilance was established in 2008.

What types of documents will be authored in this role?

The role involves authoring aggregate reports, risk management plans, and other regulatory/clinical documents needed throughout the product’s life cycle.

Can I expect to participate in training programs?

Yes, active participation in trainings and development is a key responsibility of the position.

Bringing expertise to deliver medicines our world can trust.

Science & Healthcare
Industry
501-1000
Employees
2008
Founded Year

Mission & Purpose

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.