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Form of workJob Description
Who Are We?
Founded in 1997 and built upon 26+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.
Who Are You?
You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.
What is the Primary Objective of the Medical Writer?
You are responsible for the planning, writing, reviewing, editing, formatting, and finalization of clinical study reports, clinical protocols, investigator brochures, package inserts, and regulatory submission documents (e.g., INDs, briefing documents, clinical plans and summaries, integrated analysis summaries). You may also assist in the development of scientific posters, journal manuscripts, etc. as needed.
Your Main Responsibilities and Duties Include:
- You will participate and supervise the development of clinical, regulatory, and scientific documents for publication and submission to regulatory agencies as well as be responsible for coordinating the contributions of the different functions involved.
- You will summarize data from statistical tables and other sources as needed.
- You are responsible for the maintenance and tracking of the versions of these documents during development and approval process.
- You will ensure that all sections of these documents are complete and comply with the applicable guidelines & regulations.
- You will make certain that the documents are reviewed and approved by designated personnel.
- You will be responsible for maintaining an electronic copy of each approved document.
To Succeed in this Position:
- You will have at minimum a BA/BS in a scientific, medical or statistical discipline; MA/MS or PhD in a scientific, medical or statistical discipline preferred.
- 2-3 years’ experience writing scientific or medical articles, At least 2 years’ experience in a CRO or pharmaceutical company environment preferred; an understanding of medical terminology and statistical methods; strong computer skills including word processing and presentation software. Experience in preparation of clinical/regulatory documents (e.g., clinical protocols, INDs, NDAs) is preferred.
- Medical Writer vs. Sr. Medical Writer designation will be determined by the experience level of the candidate.
- You must be knowledgeable of regulatory reporting guidelines and Good Clinical Practices.
- You must be able to interpret statistical analysis of clinical trial data.
- You must be able to work independently and as a team member.
- You must have high attention to detail.
The most likely starting base pay range for this position is $100,000 - $135,000 per year. Several factors, such as experience, tenure, skills, geographic location and business needs will determine an individual’s exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.
We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.If you are smart and good at what you do, we welcome you to apply!
