Integrium is a full-service (CRO) Firm focused on drug and device development within the therapeutic areas of Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Diseases.
Integrium is looking to hire a part time Medical Writer to work remotely. The Medical Writer is responsible for researching, writing, and editing clinical reports as well as summarizing data from clinical studies for submission to regulatory agencies and for publication and/or presentation to ensure the company's plans and objectives are met. He/she will also be expected to support our Project Leaders and MDs in clinical protocol development. Finally, our Medical Writer will be expected to interact with all functions within the company.
*OUR MEDICAL WRITER CAN EXPECT TO WORK 20-30 HOURS PER WEEK*
Education and experience:
- BA or BS in life sciences (including BSN) or MS in life sciences and a minimum of 2 years writing experience in the pharmaceutical/biotechnology sector. CRO experience is a plus.
- Experience in Regulatory Writing for a pharma/biotech company, or CRO.
- Outstanding communication skills, with the ability to work with global clients in a diplomatic and effective manner.
- Previous experience writing a Clinical Study Report (CSR).
- Experience writing protocols.
- Experience with hyper-linking.
- Superior writing ability, with attention to grammar and detail.
- Collaborative attitude- understanding the needs and functions of colleagues in Biostatistics, Data Management, Project Management, etc.
- The ability to take initiative and improve upon tasks/processes if a need to do so is recognized.
- Participation in updates to SOPs and WIs as requested.
- Staying up-to-date on best practices in Medical Writing, including updates to international or federal guidelines (including ICH and FDA).
- Extensive capabilities in writing and editing using MSWord and Adobe Pro. Additional software applications or extensions may be explored as a part of this position.
Integrium also provides a 401(k) with employer match
Equal Opportunity/Affirmative Action Employer
Integrium, LLC strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.