Individual Contributor, Medical Writing, Pharmaceuticals
The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure adherence to GCP, ICH guidelines, and SOPs.
This position will be responsible for quality review of all Medical Writing deliverables to ensure accuracy and consistency of message. This includes a check for number accuracy against source documents and for consistency within given document and between associated documents per MW SOPs and internal procedures. Provide oversight for compilation and accuracy of CSR appendices and will ensure templates are applied consistently, and writing style is consistent across documents (within and across programs). You will also be responsible for basic copyediting (spelling, punctuation, grammar) and technical formatting of documents.
Great interpersonal skills are needed as you will be working closely with the Regulatory Operations group, Knowledge Management Services, Clinical QA, and CROs/vendors (as needed)
Coordinate with various functional areas in Clinical Development and Medical Affairs, Regulatory, Clinical Quality Assurance, Knowledge management Services, and Biostatistics, in preparation of clinical and regulatory documents
Act as Lead Medical Writer at Project level in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and SOPs
Take a lead role in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices
Represent Medical Writing on clinical teams
Plan and coordinate work with in-house Medical Writers and outside CROs to ensure quality deliverables within assigned time frames
6 months +
Experience in clinical documents related to late phase studies.
Candidates should have a bachelor’s degree, preferably in a biological science, and direct experience working in clinical drug development or related area
5+ years of industry experience as Medical Writer/Clinical Editor/QC specialist
Experience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas is a plus
Experience in working with cross-functional teams and engage/escalate to ensure quality deliverables in planned time frame
Internal Number: 700
About GForce Life Sciences
GForce Life Sciences connects highly coveted consultants to the needs of life sciences leaders. Regulatory pressures, altering market demands and healthcare refinement are changing the landscape of the global life sciences industry. Patients, providers, payers, and regulators are seeking a higher quality of care and better therapeutic benefits, along with reduced costs and enhanced transparency.
With a 98% success rate, GForce Life Sciences has worked with some of the world’s leading pharmaceutical and medical device companies to address these challenges by providing consultants to assist our clients in delivering on the promises they have made to their clients (internal and external). GForce recognizes that there is no “one-size-fits-all” approach to achieving growth and battling industry-wide challenges, therefore we begin with your specific needs and work from there to identify the consultant or team that is the best fit.
Unlike larger, “factory firms,” our boutique approach allows us to hand-pick and closely monitor the best consultants for your company and projects. Finally, we back our services with the industry’s leading technology infrastructure, assuring agile, transparent, personalized consulting solutions and business reporting intelligence.