Nuventra is seeking a Scientific/Medical Writer to support our expanding clientele. The successful candidate will act as a lead writer on a diverse set of scientific, regulatory, and technical documents. This is an early career (but not entry level) position. As such, prior scientific and/or medical writing experience is expected.

Responsibilities: 

  • Author and review scientific, regulatory, and technical documents, including clinical protocols, clinical study reports, pharmacokinetic/pharmacodynamic reports, analysis plans, drug development plans, Investigational New Drug applications (INDs), marketing applications, Investigator Brochures, FDA meeting requests and briefing documents, scientific manuscripts, and others
  • Perform literature searches/reviews and write summary reports of findings
  • Maintain a detailed knowledge of FDA and ICH guidelines and other regulations, including those related to the content and format of regulatory documents 
  • Develop/maintain adequate proficiency with clinical pharmacology concepts and drug development principles
  • Work in a team environment with other medical writers and drug development experts to write and finalize deliverable documents
  • Function as a flexible resource for clients and internal staff
  • Actively participate in meetings with both internal and client teams
  • Contribute to internal process development, template generation and maintenance, and training initiatives

Qualifications: 

  • MS or PhD in a scientific field, or PharmD
  • At least 2 years of medical or scientific writing experience, preferably in an industry setting (pharma, biotech, consulting). Preference will be given to candidates with demonstrated experience authoring clinical study reports or other regulatory documents (e.g., eCTD nonclinical, clinical, or quality/CMC summaries) in support of FDA, EMA, or similar regulatory body submissions
  • Team player who is comfortable working simultaneously across multiple dynamic project teams
  • Ability to prioritize and perform required tasks independently and with limited guidance
  • Ability to identify and summarize important information from source documents, including subject matter that may be outside the writer’s prior experience
  • Ability to communicate complex scientific concepts and technical details to team members, clients, and regulatory authorities
  • Flexibility to address urgent requests quickly and efficiently within tight deadlines while maintaining an exemplary level of quality
  • Comfortable being a client-facing member of Nuventra’s project teams

Benefits and Perks:

  • Great Medical, Dental, and Vision plans (Vision is covered 100% for all employees and their families)
  • 401(k) and student loan matching
  • Flexible work environment including weekly remote work options
  • Paid childbirth and childcare leave
  • Paid 5 week sabbatical after 5 years of employment
  • Stocked kitchen with drinks, goodies, and snacks
  • Frequent company and team-building events
  • Monthly gym reimbursement
  • 8 hours of paid volunteer time-off

Diversity is a key to success. We are an equal opportunity employer and welcome applicants of all backgrounds, experiences, and perspectives.

Apply for this Job

* Required
  
Attach Dropbox Google Drive Paste
  
Attach Dropbox Google Drive Paste
When autocomplete results are available use up and down arrows to review
+ Add Another Education

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Nuventra Pharma Sciences are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.