Medical Writer (Contractor)

Sitero LLC•Raleigh, NC

1d•Remote

About The Position

The Medical Writer creates documents pertaining to both pre-marketing & post-marketing clinical trials, medical affairs, and safety data to support product development, license application, and post-marketing maintenance. This role is integral to a group of safety professionals within Sitero and involves close collaboration with safety teams in Contract Research Organizations (CROs) and partners. The individual must maintain up-to-date medical knowledge, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance, and risk-management practices.

Requirements

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

Nice To Haves

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.

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