Medical Writer
Company: Innova
Location: San Rafael
Posted on: May 25, 2025
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Job Description:
Innova Solutions has a client that is immediately hiring for a
Senior Medical Writer
You can get further details about the nature of this opening, and
what is expected from applicants, by reading the below.
Position type: Full time Contract
Duration: 12 months
Location: San Rafael, CA (Hybrid 1 or 2 days onsite)
As a(n) Senior Medical Writer you will:
Seeking candidates who are regulatory medical writers (not Medical
Communication)
The Contract Medical Writer applies advanced documentation
preparation and document project management skills to assist in the
development, drafting, review, editing, and finalization of
documents used in conducting clinical studies and reporting
clinical study results for regulatory submissions and
publications.
RESPONSIBILITIES:
Drafts and edits documents used for submissions including CTDs and
RtQs
Drafts and edits documents used in conducting and reporting the
results of clinical studies, including protocols, protocol
amendments, and informed consent forms
Drafts and edits documents used in reporting aggregate safety and
efficacy information for a molecule, such as investigator's
brochures and periodic safety reports (PSURs, DSURs, etc.)
Manages study team participation in the preparation of such
documents, including calling/running meetings, developing and
managing timelines, and managing the document review and comment
adjudication processes
Adheres to departmental procedures and practices and technical and
industry standards during all aspects of work.
Works effectively with cross-functional groups within client
Other tasks as assigned.
SUPERVISOR RESPONSIBILITY None.
CONTACTS
Clinical Medical Writing, Biostatistics, Clinical Data Management,
Statistical Programming, Clinical Operations, Medical Affairs,
Medical Directors, Regulatory Affairs, Legal, Commercial,
Pharmacology/Toxicology, Corporate Compliance, Project management,
Pharmacovigilance.
EQUIPMENT
Access to corporate computer network, production computing
environment, and MS Windows software.
Skills:
Fulfills one of the following:
Medical writer in the pharmaceutical industry
Medical or scientific writing experience as a primary job
responsibility
Skill and Experience:
At least 6+ years' experience required
Familiar with the drug development process (discovery to market),
clinical study protocol design and study conduct, and documentation
required for the conduct of clinical studies.
Familiar with clinical study data collection and results
reporting.
Previous protocol development experience required.
Experience writing, reviewing, or editing protocols and clinical
study reports highly preferred.
Experience writing, reviewing, or editing INDs and BLA/NDAs highly
preferred.
Intermediate to advanced applied knowledge of routine document
content preparation, including the use of style guides, medical
dictionaries, and guidance documents that prescribe content.
Intermediate to advanced applied knowledge of AMA, CBE, and Chicago
Style Manuals.
Ability to interpret basic tabular and graphical clinical data
presentations.
Ability to create basic tables using AMA style (e.g., Schedule of
Events).
Intermediate applied knowledge of basic clinical laboratory
tests.
Basic understanding of the concepts of coding dictionaries (MedDRA,
WHO Drug).
Basic understanding of biostatistical and clinical research
concepts.
Proficient in Microsoft Word (including the use of templates),
Excel, and PowerPoint.
Experienced with scanners, printers, and copiers.
Basic knowledge of regulatory requirements and guidances associated
with 'standalone' regulatory documents (e.g., protocols,
investigator brochures, and clinical study reports).
Capable of working on multiple tasks and shifting priorities.
Capable of leading a cross-functional team under strict timelines,
including calling/running meetings and managing team review and
comment adjudication stages of document preparation.
Good conflict management skills.
Motivated and shows initiative.
Detail oriented. Capable of well organized, concise and clear
written and verbal communication.
Capable of comprehending complex scientific concepts and
translating them into clear, concise, appropriately referenced text
that meets regulatory requirements.
Effective at explaining writing principles to a varied audience
both in individual and group settings; basic presentation
skills.
Education:
EDUCATION
Bachelor's or higher degree; scientific focus desirable.
Evidence of medical writing career development desirable, eg,
American or European Medical Writers Association certificate,
Editor in Life Sciences certificate, or relevant training through
Drug Information Association.
Qualified candidates should APPLY NOW for immediate consideration!
Please hit APPLY to provide the required information, and we will
be back in touch as soon as possible.
We are currently interviewing to fill this and other similar
positions. If this role is not a fit for you, we do offer a
referral bonus program for referrals that we successfully place
with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Namrata Gautam
PHONE: (+1) 314-523-1818
EMAIL: Namrata.Gautam@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $65- $70 per hour
*Pay range offered to a successful candidate will be based on
several factors, including the candidate's education, work
experience, work location, specific job duties, certifications,
etc.
Benefits: Innova Solutions offers benefits( based on eligibility)
that include the following: Medical & pharmacy coverage,
Dental/vision insurance, 401(k), Health saving account (HSA) and
Flexible spending account (FSA), Life Insurance, Pet Insurance,
Short term and Long term Disability, Accident & Critical illness
coverage, Pre-paid legal & ID theft protection, Sick time, and
other types of paid leaves (as required by law), Employee
Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in
Atlanta, Georgia, Innova Solutions employs approximately 50,000
professionals worldwide and reports an annual revenue approaching
$3 Billion. Through our global delivery centers across North
America, Asia, and Europe, we deliver strategic technology and
business transformation solutions to our clients, enabling them to
operate as leaders within their fields.
Recent Recognitions: Named One of America's Best Employers for New
Grads by Forbes (2024
Named One of the Best Companies to Work For by U.S. News & World
Report (Private Companies List, 2024-2025)
One of the Largest IT Staffing Firms in the US - Ranked #3 by
Staffing Industry Analysts (SIA, 2024)
One of the Largest Staffing Firms in the US - Ranked #13 by
Staffing Industry Analysts (SIA, 2024; includes Innova Solutions,
Volt, & HireGenics)
Named One of the Top Ten Private Companies in Atlanta by the
Atlanta Business Chronicle (2023)
One of the Largest Certified Minority Business Enterprises (MBEs)
in the United States (NMSDC, 2024)
AWS Advanced Tier Services Partner with 100+ certifications
Website: https://www.innovasolutions.com/
Innova Solutions is an Equal Opportunity Employer and prohibits any
kind of unlawful discrimination and harassment. Innova Solutions is
committed to the principle of equal employment opportunity for all
employees and to providing employees with a work environment free
of discrimination and harassment on the basis of race, color,
religion or belief, national origin, citizenship, social or ethnic
origin, sex, age, physical or mental disability, veteran status,
marital status, domestic partner status, sexual orientation, or any
other status protected by the statutes, rules, and regulations in
the locations where it operates. If you are an individual with a
disability and need a reasonable accommodation to assist with your
job search or application for employment, please contact us at
hr@innovasolutions.com or (770) 493-5588. Please indicate the
specifics of the assistance needed. Innova Solutions encourages all
interested and qualified candidates to apply for employment
opportunities. Innova Solutions (HireGenics/Volt) does not
discriminate against applicants based on citizenship status,
immigration status, or national origin, in accordance with 8 U.S.C.
- 1324b.
The company will consider for employment qualified applicants with
arrest and conviction records in a manner that complies with the
San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance
Initiative for Hiring Ordinance, and other applicable laws
Keywords: Innova, Turlock , Medical Writer, Healthcare , San Rafael, California
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