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- Create/write/maintain clinical trial protocols & reports, standard operating procedures (SOPs), and regulatory submissions.
- Work closely with clinical research teams to gather and synthesize technical information, ensuring accuracy and compliance with regulatory standards (e.g., FDA, ICH-GCP).
- Develop and maintain informed consent forms, investigator's brochure, clinical overviews and summaries.
- Stay abreast of relevant regulations, guidelines, and industry standards governing clinical research, ensuring that all grant proposals and technical documents comply with applicable requirements.
- Craft comprehensive investigator brochure that succinctly summarizes complex clinical trial data, ensuring accuracy, compliance, and clarity for regulatory submissions and investigator teams.
- Adheres to department policies.
- Create detailed trial/research budgets and financial narratives, accurately estimating project costs and its justifications.
- Collaborate with internal (research teams) and external (IRB, CRO etc.) and other relevant teams to develop trial protocols, patents and reports.
- Identify and evaluate potential grant funding opportunities from government agencies, foundations, corporations, and other sources.
- Develop and execute a comprehensive grant acquisition and management strategy in alignment with the organization's mission and goals.
- Write, edit, and submit grant proposals, ensuring alignment with the organization's needs and funding priorities.
- Create detailed grant budgets and financial narratives, accurately estimating project costs and justifying funding requests.
- Oversee the full life cycle of grants, from application to final reporting, and monitor progress toward grant-funded goals.
- Collaborate with program managers, finance, and other relevant teams to develop grant proposals and reports.
- Utilize data and analytics to track the effectiveness of grant strategies and make data-driven improvements.
- Develop and implement stewardship plans to maintain positive relationships with funders, acknowledging their contributions and demonstrating impact.
- Writing educational contents on health and medicine.
- Promotional material for pharmaceutical and medical device products.
- Scientific articles intended for publications.
- Abstracts and posters designed for conferences.
- Close relationship with a biostatistician
- Physical, sensory, and cognitive abilities sufficient to perform essential functions.
- Strong analytical and financial skills for budgeting and financial narrative development.
- Familiarity with government and foundation grant-making processes and requirements.
- Strategic thinking and the ability to align grant opportunities with organizational needs.
- Exceptional time management and organizational skills.
- Ability to work independently and collaboratively in a team environment.
- Good interpersonal and written and verbal communication skills.
- A degree in life science preferably a masters/doctoral degree in medicine, biology or pharmacy.
- Minimum of 3-5 years of experience in medical writing, grant writing, and/or clinical research, with a focus on clinical trials.
- Strong understanding of clinical research methodologies, including study design, patient recruitment, data collection, and analysis.
- Proficiency in interpreting and applying regulatory requirements, such as FDA regulations, Good Clinical Practice (GCP) guidelines, and international standards.
- Strong understanding of clinical trial/grant management and reporting.
- Prolonged periods of sitting at a desk and working on a computer and standing, bending and moving.
- Must be able to lift up to 15 pounds at times.
- If applicable, manage and mentor a team of technical writers and coordinators.
- Health Insurance: 100% Employer-sponsored health insurance, including a low-deductible health plan through UHC, Vision, and Dental.
- Additional Insurance: Large employer monthly allotment for Disability, Life insurances, Cancer coverage, Accident policies, Hospital Indemnity coverage, and more through multiple supplemental companies.
- Retirement: Highly matched 401(k).
- PTO & leave: Generous PTO with accrual and carry-over opportunities, annual sick leave, annual bereavement leave, maternity leave, and more.
medical/grant writer - Gillette, WY, United States - Hoskinson Biotechnology
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Description
The duty of a medical/grant writer entails crafting clearly and concisely structured documents that effectively convey, scientific, clinical, educational and promotional information. The medical/grant writer will possess a strong background in medical/technical writing, particularly in the context of clinical trials/research, along with the ability to craft compelling grant proposals tailored to funding agencies' requirements. This role requires a deep understanding of clinical research methodologies, regulatory requirements, and grant writing best practices. Will play a pivotal role in identifying funding opportunities, developing grant proposals, and building and maintaining relationships with grantors and funding agencies. A Medical/Grant writer will be responsible for producing well-structured documents presenting scientific, clinical, educational and promotional information clearly and concisely.Regulatory Writing:
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for HBT to hire me. If I am hired, I understand that either HBT or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of HBT has the authority to make any assurance to the contrary.
I attest with my submission of this application that I have given to HBT true and complete information on this application. No requested information has been concealed. I authorize HBT to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.