Job Title: Life Sciences - US - Medical Writer IV

Work Location: Remote

Role Description: The Medical Writer tasks include:

- 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

Qualifications/Experience:

- Minimum of a BA/BS in Life Science; graduate degree preferred

- 10+ years pharmaceutical/biotechnology experience related to clinical research

Required Skills Include:

- 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; medical device experience preferred

- BA/BS + 3 years; MS/PhD + 1 years

- Experience with ICH and electronic submission guidelines for regulatory report+C58s+C58 written and verbal skills

- Good leadership, communication, and influencing skills

- Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization

- Ability to identify process improvements, manage change successfully, work with newer technologies, and foster an innovative atmosphere

- Applies good judgment and demonstrates initiative to resolve issues

- Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies preferred

- Ability to function in an ambiguous environment

Job Types: Full-time, Contract

Pay: $65.00 - $75.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• clinical and regulatory submission documents: 3 years (Preferred)

Work Location: Remote

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