Medical Writer (Contractor)

Sitero; Polska; Teletrabalho; PLN 83 000 - 165 000; Tempo parcial

Resumo da oferta

Sitero is seeking a Medical Writer in Poland (Remote) within Drug Safety. The role focuses on creating safety documents for pre- and post-marketing trials, involving regulatory reports and pharmacovigilance processes.

Responsibilities include composing PSURs and CSRs, performing signal assessment, and mentoring associates, with an hourly contract and flexible hours to fit client requirements.

Qualificações

• Minimum 2 years of experience in Medical Writing.
• Degree in Life Science/Pharma or Equivalent.

Responsabilidades

• Analyze safety data (clinical and non-clinical).
• Author and review PSURs, PBRERs, PADERs, DSURs.
• Prepare Risk Management Plans and Clinical Study Reports.
• Conduct qualitative and quantitative signal assessment.
• Perform literature searches and present relevant articles.

Conhecimentos

Medical writing

Verbal communication

Written communication

Interpersonal skills

Organization & prioritization

multitasking

Formação académica

Degree in Life Science/Pharma or Equivalent

Ferramentas

Microsoft Office Suite

Descrição da oferta de emprego

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title: Medical Writer
Location: Poland (Remote)
Function: Drug Safety

DESCRIPTION

The Medical Writer creates documents pertaining to both pre-marketing & post-marketing clinical trials, medical affairs, safety data, to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These include but is not limited to aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), Risk Management Plans, Signalling, Labelling documents, Clinical Study Reports, Protocols. The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Analyses, reviews, and interprets safety data, both non-clinical and clinical and any other relevant sources
• Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities
• Authoring and review of Risk Management Plans as needed.
• Authoring and Review of Clinical Documents like Clinical Study Reports, Protocols
• Qualitative and Quantitative Signal Assessment
• Performing literature search and presentation of relevant articles for the aggregate reports.
• Management and reconciliation of relevant process trackers
• Subject matter expert (SME) along with training and mentoring of individuals.
• Generation of Periodic Safety Line Listings (PSLL) from safety database
• Exposure in handling regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
• Providing reliable support for high priority Ad-hoc activities
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines
• Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community
• Training and mentoring of Pharmacovigilance associates

EDUCATION AND EXPERIENCE REQUIRED

• Minimum 2 years of experience in Medical Writing
• Degree in Life Science/Pharma or Equivalent

PREFERRED SKILLS

• Preferred: 2-6 years of experience in Medical Writing
• Proficient computer knowledge and computer keyboarding skills.
• Proficient with Microsoft Office Suite (Outlook, Word, Excel).
• Strong verbal, written and interpersonal communication skills.
• Strong organization and prioritization skills; able to multitask.
• Flexibility to adapt and meet fluctuating business priorities.
• Able to occasionally work extended and/or flexible schedule to meet client requirements.
• Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
• Excellent verbal, written and presentation skills.
• Innovative, collaborative, initiative-taker.

COMPENSATION & BENEFITS

Hourly rate commensurate with Drug Safety medical writing experience level

EMPLOYMENT TYPE

Contract

COMMITMENTS

• Contract, as-needed agreement to be extended in the form of a Scope of Work consulting document

DISCLAIMER

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Originally posted on Himalayas