Medical Writer

Type of job: full-time

For my client, prestigious biotechnological company I am looking for Medical Writer.

Department:

Clinical Development, specialization Oncology

Responsible To:

Chief Medical Officer

The purpose of this position is to research, create and revise various documents associated with clinical research. The documents may be submitted to Health Authorities worldwide to support clinical development and registration of drug candidates as well as to communicate study data both internally and externally, including publication in peer-reviewed scientific journals.

Key Activities and Responsibilities: Medical writing activities that support the preparation of regulatory & clinical documents required to support global drug development and registration activities. Serve as the primary medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory and scientific departments. Manage the quality, accuracy, compliance with internal & external standards and the timely production of English-language documents using electronic document management system. Manage the writing, editing and reviewing of diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries and other medical/regulatory documents (including regulatory summary documents). Develop, implement and manage templates & documentation format required for standardization of regulatory & clinical documentation to support development and registration activities. Participate in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide & poster presentations. Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to guidelines/SOPs including: distribute drafts, chair review meetings, incorporate revisions, document key project events and complete sign-off procedures. Create/maintain audit system/trails of all document changes. Perform literature searches/reviews as necessary to obtain background information for development of documents.

Competences, Skills and Qualification: Ability to understand and interpret data/information and its practical application

Excellent English written/oral communication skills

Excellent scientific writing and ability to adapt style & content for different target audiences

Excellent technical editing and QC skills

Accurate and detail-oriented, with excellent inter-personal skills

Strong time and project management skills

Demonstrated ability to lead others to complete projects

Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management and medical terminology

Experience advancing numerous projects simultaneously

Experience working in a matrix team environment

Computer skills

Ability to search and scan various internal & external databases

Education

Doctorate degree & 2 years of directly related experience –or– Master's degree & 4-6 years of directly related experience –or– Bachelor's degree & 6-8 years of directly related experience - Degree(s) should be in Life Sciences/Health Related Sciences from an accredited college or university

Experience

2-3 years of medical writing experience in a biotech or pharmaceutical company, preferably in the oncology therapeutic area

Knowledge of global regulatory publication guidelines (FDA, EMA, ICH, etc.) and best practices

Proficient in pertinent software (eg, MS Office, EndNote, Adobe Illustrator)

Must be knowledgeable in industry trends for study reports and international dossier preparation (eg, IND/CTA/NDA/BLA/MAA),

Offer:

· Interesting work

· Very good salary

· Company benefits (e.g. bonus, pension contribution, 1 week extra holiday, sick days, multisport, meal vouchers etc.)

· Professional growth, good team

Start date is upon agreement. In case of your interest please contact Lada Drobisova.

In sending your CV you give your consent to processing and holding of your personal data in accordance to Act. No. 101/2000 Coll. regarding personal data protection by LD Human Resources s.r.o., ID: 24275336 until a written form revocation. Your personal data can be provided to third persons in order to obtain employment, namely after prior approval.

Contact:
Ing. Lada Drobišová, MBA

E-mail:
lada.drobisova@LDHR.cz

Telephone:
+420 722 950 102

Updated: 28.2.2018