Freelance Medical Writer, United States - L
- Employer
- ClinChoice
- Location
- United States
- Salary
- Competitive
- Start date
- 18 Nov 2022
- Closing date
- 17 Dec 2022
View more
- Discipline
- Medical Communications, Medical Writing
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
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:
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Company
ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.
We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
- Website
- https://clinchoice.com/
- Telephone
- +44 1628 566121
- Location
-
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom
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