Medical Writer

Company: Innova
Location: San Rafael
Posted on: May 25, 2025

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, San Bruno , Medical Writer, Healthcare , San Rafael, California