Medical Writer (In Vitro Diagnostics)

IDEALLY LOOKING FOR:

Advanced Scientific Degree
Experience working in assay development
Medical Writing experience for IVD devices, including documents such as:
Clinical Validation Plans
Parts of pre-submissions for FDA
Clinical protocols for retrospective studies for clinical validation
Quality documents and respective SOPs

SUMMARY

The Medical Writer will collaborate with members of cross-functional teams to prepare high-quality regulatory documents and clinical study-related documents within agreed-upon timelines.

Essential Duties and Responsibilities:

● Collaborates with medical directors, clinical scientists, biostatisticians, regulatory leads and other cross-functional team members to review clinical and technical information and ensure accurate and clear communication in relevant documents

● Applies document preparation and project management skills in the development, drafting, review, editing, and finalization of documentation related to clinical validation plans, conducting clinical studies and reporting clinical study results for regulatory submissions and other communications.

● Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed

● Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes

● Works closely with teams to set realistic timelines for deliverables, completes documents according to agreed-upon timelines and follows up with teams as needed to meet internal and external timeline commitments

● Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines

● Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and adhere to required formatting and style standards

Education/Experience:

● At minimum Bachelor degree or equivalent in medical-related or life science field; advanced degree preferred

● At least 5 years of medical writing experience, preferably for in vitro diagnostics (IVD); pharmaceutical, biologics or medical device experience also acceptable.

● Additional qualifications (AMWA, EMWA, or RAC training; CMPP certification) preferred

● Ability to read, write and speak fluent English; excellent verbal and written communication skills

● Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.

● Strong interpersonal communication (written and verbal), organizational and prioritization skills.

● Able to work effectively under a fast-paced and changing environment.

● Strong work ethic and demonstrated ability to deliver assignments on time.

● Proficient with office automation tools, such as Microsoft Office and the Google suite of applications

● Proficient with reference management software, such as Zotero