Description:
Location: United States - home-based

Schedule: Freelance Medical Writer - 0.4 FTE

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Freelance Medical Writer to join one of our sponsors in the United States for leading clinical care and research, compassionate patient experience, and state-of-the-art technology.

CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.

The Medical Writer is responsible for supporting the clinical research program by collaborating with Principal Investigators and study-related individuals to write clinical trial protocols, informed consent documents, and other study-related documents. He/she will be integrally involved with the writing and editing of clinical study reports and study-related journal articles in support of investigator-initiated research, and other documents as needed

Main Job Tasks and Responsibilities:

• As a primary point of contact with Principal Investigators (PIs) to understand novel research concepts and assists the PIs to translate these ideas into high-quality, investigator-initiated clinical research protocols.
• Assists to ensure the inclusion of appropriate regulatory language related to the adverse event/serious adverse event safety reporting in clinical research protocols to comply with federal requirements.
• Coordinates with Principal Investigators to incorporate protocol revisions and updates in response to feedback received from internal committees and external organizations (e.g. FDA, external IRBs, CMS, etc.).
• Coordinates with Principal Investigators to amend clinical research protocols as needed during the clinical study.
• Collaborates with Principal Investigators to write Informed Consent Forms and other study-related documents that may be distributed to study subjects in compliance with federal requirements
• Provides mentorship and training in Medical Writing-related subject areas to Research Associates.
• Collaborates with supportive departments (pharmacy, lab, etc.) to write study-related manuals (e.g., Pharmacy Manual, Laboratory Manual, etc.) and patient-facing materials (e.g. patient instructions, drug diaries, etc.).
• Collaborates in writing and editing study-related journal articles and reports for investigator-initiated studies.
• Collaborates in writing and editing department training materials and SOPs.
• Collaborates with departmental teams to write and update templates for clinical protocols and study-related plans.
• Writes and edits other clinical research-related documents (e.g. newsletters, articles, website content, etc.) for internal use and for sub-distribution.
• Other duties as assigned

Education and Experience:

• Requires MS Master with a minimum of 5 years of experience
• Ph.D. preferred.
• Collaborative Institutional Training Initiative certification must be obtained within the first month of employment.
• Experience in medical writing is required.
• Experience in oncology and/or medical research is strongly preferred.
• Maintains Collaborative Institutional Training Initiative certification

Skills:

• Attention to detail and demonstration of quick follow-up to PI and other internal customer needs commits to quality.
• Demonstrated adaptability, handled day-to-day work challenges confidently and was willing and able to adjust to multiple demands and shifting priorities. shows resilience in the face of constraints, and demonstrates flexibility.
• Able to produce high-quality work within strict deadlines
• Shows work commitment: sets high standards of performance. pursues aggressive goals and works efficiently to achieve them
• Interpersonal skills and clear oral and written communication skills. Uses correct grammar, syntax, and format in written English
• Demonstrated ability to use critical thinking to make decisions.
• Flexible and service-oriented.
• Knowledge of MS Word and Outlook.

The Application Process

Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Medical Writer, Pharma, CRO, Clinical Research Organisation, Clinical Trials, Clinical, Home based, Oncology, Freelance, Freelancer, Contractor, Communication & Scientific Writing, Scientific Communications, Outsourced, Outsourcing, Sponsor-dedicated

Skills: Oncology, Freelance, Medical Writer, clinical trials, CRO, Medical Writing, Outsourcing Location: United States Share:

LinkedIn Facebook Twitter Email