Medical Writer

Hoskinson Biotechnology
US - Wyoming - Gillette
May 13, 2024

The duty of a medical writer entails crafting clearly and concisely structured documents that effectively convey, scientific, clinical, educational and promotional information. The medical writer will possess a strong background in medical/technical writing, particularly in the context of clinical trials/research. This role requires a deep understanding of clinical research methodologies and regulatory requirements. AMedical writer will be responsible for producing well-structured documents presenting scientific, clinical, educational and promotional information clearly and concisely.

Regulatory & IRB Writing:

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, IRB).
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.

Medical Communications:

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

Required Skills/Abilities:

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.

Education and Experience:

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 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.

Physical Requirements:

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.

Supervisory Responsibilities:

If applicable, manage and mentor a team of technical writers and coordinators.

• This is an onsite job opening
• Benefits:

Health Insurance: Employer-sponsored health insurance, including a low-deductible health plan through Cigna, Vision, and Dental.
Additional Insurance: Employer monthly allotment for Disability, Life insurances, Cancer coverage, Accident policies, and more through a supplemental company.
Retirement: Highly matched 401(k).
PTO & leave: Generous PTO and sick leave with accrual and carry-over opportunities.
Continuing or Additional Education: HH&WC will assist in the professional development of all employees with HR approval.

EEO Statement:

Hoskinson Health and Wellness Clinic is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and applicants. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, or any other protected status in accordance with applicable federal, state, and local laws.

DISCLAIMER: Hoskinson Biotechnology, Hoskinson Health & Wellness Clinic, Hoskinson Construction, and all associated HBT entities are an equal opportunity employer. HBT does not discriminate in employment with regard to race, color, religion, national origin, citizenship status, ancestry, age, sex (including sexual harassment), sexual orientation, marital status, physical or mental disability, military status or unfavorable discharge from military service or any other characteristic protected by law.

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.

Read the full job description and apply online on the recuiter's web-site

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