The Medical Writer is responsible for the preparation of documents that support various departments, including Clinical, Regulatory, and Scientific. This individual will study-related documents, presentation, and publication needs associated with various pipeline drug (CNS) studies. This person supports the scientific and medical communication needs.
This will be a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the head of Clinical Development.
KEY DUTIES & RESPONSIBILITIES
- The Medical Writer is responsible for clinical content creation, including the preparation of clinical study protocols, protocol amendments, consent forms, documents for regulatory submissions, interim study reports, newsletters, presentations, final CSRs and other material based on clinical trials and registries
- Writes/reviews scientific manuscripts, congress abstracts, and scientific meeting presentations aligned with journal and congress guidelines
- Write IND modules, NDA modules and other related regulatory documents
- Write clinical study reports, protocols, and protocol amendments
- Coordinate quality control reviews of those documents and maintain audit trails of changes
- Interact closely with the sponsor, and other Vistagen subject matter experts.
- Writes on white space topics or on post hoc analyses which answer key clinical questions within and outside the United States.
- Clinical content preparation for study investigator meetings, interim data analyses and other interim external and internal meetings regarding clinical studies.
- May create symposia (non-CME), speaker's decks, post-meeting slide decks, topical slide decks and other Medical Education modules- as needed.
- Interacts extensively with internal medical monitors, clinical research scientists, clinical trial managers, statisticians, other medical writers as part of publication teams. Develops relationships/partnerships with study investigators. Interacts externally with journals, conference organizers, and freelance/contract medical writers. Interacts with other groups as needed to ensure that clinical data is represented accurately and correctly in any published literature, slide sets, and other materials prepared by these groups. Organizes, conducts and leads document production meetings and other meetings as necessary.
- Helps review documents related to clinical trials and registries to ensure appropriate evaluation and presentation of data, methodology, interpretation, and documentation.
EDUCATION, EXPERIENCE AND SKILLS:
- BA/BS Degree in the Life Sciences required (Advanced preferred)
- Experience working within Medical Device or Pharmaceutical Industry in Medical Writing and/or Clinical Research with a focus on Medical Writing
- Extensive experience in writing Clinical Research documents (e.g., protocols, consent forms, protocol amendments, CSRs, interim study reports, regulatory submission documents) and writing, editing, and submitting publications to journals and congresses.
- Therapeutic area knowledge in CNS is highly desired.
- Excellent written, analytical, verbal, and communication skills
- Ability to manage multiple projects and product responsibilities, work independently, and be self-motivated to meet deliverables on time and with quality deliverables.
- Ability to work effectively with others in a matrix environment.
- Ability to develop strategic solutions to unique, significant, and business issues
- Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other applicable best practices in the industry.
Compensation and Benefits
What we offer:
- Industry competitive compensation
- Performance-base bonuses
- Stock options
- Employee Stock Purchase Plan
- 401K plan
- A collaborative and innovative work environment at the forefront of biotech advancements.
Give your best, live wholesomely:
- Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
- FSA and HSA
- Basic Life Insurance 2x Earnings & AD&D
- Employee Assistance Program
- Healthcare advocates group to help navigate the healthcare system
- Unlimited paid time off
- Flexible work schedule
- Remote work option
- Paid Holidays
- Mental Health Days & Observance of World Mental Health Day
- Winter shut-down
- Casual work environment
We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.
The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.
Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
This position requires the ability to lift and/or move up to 25 pounds occasionally. Evening and weekend work as necessary.
The anticipated salary range for candidates who will work remotely is $100,000 to $140,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.
Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as a general description of benefits and other compensation, and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns than those currently available for the treatment of anxiety, depression, and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH80, PH15, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug of an antagonist of the N-methyl-D aspartate receptor (NMDAR). Pherines are neuroactive nasal sprays designed with an innovative proposed mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic absorption or direct activity on neurons in the brain.
Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression, and several other CNS disorders.
At Vistagen, we emphasize that mental health is foundational to living vibrant and healthy lives. We believe that healthy minds create healthy communities, and our core goal at Vistagen is to radically improve mental health and well-being worldwide – One Mind at a Time. We are change-makers committed to improving lives by developing innovative, science-based mental health care medicines with the potential to make the impossible, possible - to empower and support patients and their caregivers to achieve faster-acting efficacy without the side effects and safety concerns associated with current treatment options for anxiety and depression.
Vistagen Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation.