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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: United States (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.