Sr Scientific Marketing Writer

neteffects; San Diego (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

An innovative firm is seeking a Sr. Scientific Marketing Writer to join their medical writing team. This role involves preparing clinical study documents and collaborating with clinical teams to ensure high-quality submissions for regulatory approvals. The ideal candidate will have extensive experience in clinical writing within the medical device industry and a strong grasp of project management and communication skills. This position offers the chance to contribute to impactful projects in a dynamic and supportive environment. If you are detail-oriented and thrive in collaborative settings, this opportunity is perfect for you.

Benefits

Health insurance

Dental insurance

Vision insurance

Life insurance

Retirement plan

Flexible spending accounts

Health savings account

Qualifications

• 5+ years of clinical protocol and CSR writing experience.
• Strong organizational skills and project management expertise.
• Ability to work collaboratively with cross-functional teams.

Responsibilities

• Prepare high-quality clinical study documents for regulatory filings.
• Collaborate with clinical teams to plan and write study protocols.
• Maintain organized records of all documentation and drafts.

Skills

Clinical protocol writing

CSR writing

Regulatory approval knowledge

Team collaboration

Project management

Communication skills

Data analysis

Medical writing principles

Education

Bachelor's degree

Master's degree

Ph.D. in life sciences

Tools

Microsoft Office

Adobe Acrobat

Web authoring tools

Job description

Job Description

Sr Scientific Marketing Writer

Pay Rate: $45.50/hr - $57.00/hr
Hours: 8:00 am to 5:00 pm PST

Location: REMOTE
Duration: 7 months, with a possibility of extension or conversion if there's a business need, but not guaranteed.

Job Description:

Our client is seeking an organized, motivated, and collaborative individual for the medical writing team. The Sr. Medical Writer (temporary) will partner cross-functionally with clinical teams to lead the planning and preparation of high-quality clinical study documents. The Sr. Medical Writer is responsible for preparing clinical study protocols, clinical study reports, and study summaries to support regulatory filings for in vitro diagnostic (IVD) assays.

Responsibilities:

1. Work with scientists, medical leads, biostatisticians, and the clinical affairs team to plan, write, and edit clinical study protocols and CSRs for registrational studies.
2. Work efficiently and accurately, adhering to best practices and departmental standards for terminology, content management, and reuse.
3. Release finished documentation to the Document Control Management system, and maintain organized records of all materials, drafts, and previous versions.
4. Quickly learn and apply new tools, processes, and standards as needed.
5. Be adaptable and forward-thinking in the face of technological or organizational change.
6. Propose improvements to authoring tools as needed.

Requirements:

• Clinical protocol and CSR writing experience in the medical device/IVD industry.
• Experience with regulatory approval of IVD/medical devices is preferred.
• Knowledge and familiarity with genomic data generated by sequencing platforms.
• Excellent team skills, written and oral communication skills.
• Broad experience in study design and data analysis for IVD/medical devices; experience with industry publications is a plus.
• Ability to gather input from multiple stakeholders and deal effectively with ambiguous or missing information.
• Strong organizational skills and excellent time and project management.
• Understanding of medical writing principles, content management, and reuse.
• Expertise in Microsoft Office, Adobe Acrobat, and web authoring tools.
• Proficient in English, with excellent grammatical and editorial skills.

Experience/Education:

• Typically requires a minimum of 5 years of related experience with a Bachelor's degree; or 3 years with a Master's; or a PhD without experience; or equivalent work experience.
• Ph.D. or M.S. in life sciences preferred.

Personal Attributes:

• Team player
• High attention to detail
• Excellent written and verbal communication skills

Must Have:

• Clinical Data
• Clinical Studies
• Clinical Trials

Nice to Have:

• Document Control
• Document Review
• Excellent Verbal and Written Communication
• Microsoft PowerPoint
• Microsoft Word
• Report Writing
• Teamwork
• Technical Writing

Benefits:

Health insurance, Health savings account, Dental insurance, Vision insurance, Flexible spending accounts, Life insurance, Retirement plan. Employee contributions apply.

Equal Opportunity Employment:

All qualified applicants will receive consideration without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

About the company

neteffects is a leading IT staffing and recruiting firm based in St. Louis, Missouri, providing talent, business process, and technology solutions. Better Mondays Start Here!