Medical Writer

GForce Life Sciences; United States; Remote; USD 73,000 - 135,000; Full time

Job summary

A leading pharmaceutical client is seeking a Medical Writer to join their Global Regulatory Affairs team. Responsibilities include managing the writing of crucial technical documents for regulatory submissions with a focus on quality and compliance. Candidates should possess strong writing skills and relevant experience in the pharmaceutical industry. This position offers the flexibility of part-time or full-time remote work, along with a comprehensive benefits package that includes medical, dental, and vision coverage.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 7 years with BA/BS or 4 years with MS/PhD.
• 4-7 years in pharmaceutical/biotech related to clinical research.
• Experience in medical writing for regulatory submissions.

Responsibilities

• Manage writing activities across various projects.
• Contribute to clinical and regulatory submission documents.
• Ensure writing meets quality standards and adheres to guidelines.

Skills

Writing skills

Ability to interpret scientific data

Attention to detail

Education

BA/BS or MS/PhD

Job description

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a medical writer within our clients Global Regulatory Affairs department. The consultant will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation.

The CW will manage processes intended to increase project efficiency, quality, and the timely achievement of deliverables and ensure the needs of business are met, particularly in the preparation of accurate, timely, and multidisciplinary documents submitted to regulatory agencies worldwide.

Description

• Proactively manages writing activities across assigned projects as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs.

• Contributes to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents.

• Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to protocols, clinical study reports, Investigator’s Brochures [IBs], annual reports, HA briefing packages and response documents, submission summary modules, and integrated data summary reports).

• Adheres to medical writing practices/systems/tools to support clinical studies in order to meet company goals and objectives.

• Assures that standardized practices are implemented and maintained across all therapeutic areas.

• Engages with team members to ensure medical writing continues to deliver value to the business.

• Ensures medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations.

• Supports innovation initiatives within the Medical Writing Group.

Mandatory Requirements

• BA/BS + 7 years; MS/PhD + 4 years

• 4-7 years pharmaceutical/biotechnology experience related to clinical research

• Demonstrated expertise in writing/developing clinical documents in support of global regulatory submissions

• Ability to interpret and organize scientific and clinical data

• Medical writing experience in Pharma, Biotech and/or CRO

• Experience with ICH and electronic submission guidelines for regulatory reports.

Term & Start

• 12-month contract, open to 12+ month extension
• 2 Video Interviews - Start 2 weeks from an offer
• Open to part-time or full-time
• REMOTE – EST hours
• Benefits available (Medical, Dental, Vision, 401k)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Writing/Editing, Quality Assurance, and Science

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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