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Senior Medical and Regulatory Writer (Remote / Home Based)
at Clinipace Worldwide
Clinipace is a global full-service clinical research organization (CRO) serving the unique needs of venture-backed, mid-tier and strategic pharmaceutical, biotechnology and medical device firms. We help our customers advance drug candidates to deliver successful stakeholder and patient outcomes. We leverage extensive therapeutic knowledge, clinical trial expertise, and comprehensive innovative technology to support life science firms in achieving some of their most important goals: Executing regulatory strategies, optimizing clinical development timelines and completing high quality trials. We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development. Clinipace associates are passionate about their lives and bring that same passion to their work at Clinipace.
United States | Colorado (Boulder)
Job Title: Senior Medical and Regulatory Writer
Job Location: United States (Any location, home based regional)
The Senior Medical and Regulatory Writer works independently to prepare and deliver clinical and regulatory documents for a wide range of therapeutic areas, performing the tasks listed below.
Job Duties and Responsibilities:
- Write, edit, format, compile and review assigned documents requested by internal cross-functional teams and/or clients
- Create, monitor and maintain timelines for medical and regulatory writing projects
- Prepare clinical and regulatory documents, e.g., clinical study reports, protocols and amendments, investigator brochures, clinical and non-clinical summary documents, etc.
- Coordinate overall quality review of documents
- Manage large and complex medical and regulatory writing projects which may include supervision of other medical writers and quality reviewers to ensure delivery of documents according to timelines and within budget and to acceptable quality standards
- Provide support to other medical and regulatory writers to ensure delivery of documents according to timelines and within budget and to acceptable quality standards
- Support business development in project bids and new business proposals
- Mentor and/or supervise Medical and Regulatory Writers and Quality Reviewers as required
- Train other Medical and Regulatory Writers and Quality Reviewers as required
- Support Regulatory Strategic Development team efforts on medical and Regulatory Writing projects
- Participate in client meetings and other project-related meetings and teleconferences as needed
- Any other activities related to the position as required by direct supervisor
Supervisory Responsibilities: May supervise less experienced members of the medical and regulatory writing team.
- A university degree in the field of Science or Medicine, graduate/postgraduate degree highly preferred
- At least 5 years of relevant Medical and Regulatory writing experience in the Pharmaceutical industry, CRO experience a plus
- Proven track record in preparing clinical and regulatory documents with minimum supervision
- Strong written and verbal communication skills in English
- Strong computer skills, including Microsoft Office
- Proficiency in medical terminology
- Ability to manage large and complex medical and regulatory writing projects
- In-depth knowledge of local and national guidance and regulations relevant to medical and regulatory writing
- Ability to exercise judgment within defined procedures and practices and to determine appropriate action independently
- Excellent attention to detail
- Superior problem-solving skills
- Ability to work in a digital environment using computer systems
- Ability to work within a team
- Ability to manage a team
- Ability to work on global projects in a multi-cultural environment
- Ability to travel, if needed
The company will not accept unsolicited resumes from third party vendors.