1+ months

Director, Medical Writing, San Diego, CA

Kelly Services
San Diego, CA 92108
**Director, Medical Writing, San Diego, CA**

We are hiring a talented Director, Medical Writing. The Director will be a strategic, hands-on medical writing expert with responsibility for leading and managing a team of writers and for preparing high-quality clinical regulatory documents. The Director will contribute both strategic and operational perspectives. The Director will make significant contributions to department initiatives and will collaborate with key functions across the organization. This role will report to the Head of Medical Writing and will be a key member of the Medical Writing leadership team.

**Role Responsibilities**

+ Plan, prepare, write, edit, format, and finalize regulatory documents, and clinical research publications. Documents will include, but are not limited to: IND, CTA, clinical and non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, briefing books, annual reports/development safety update reports (DSURs), and well as manuscripts and posters that support clinical and translational research activities

+ Partner with regulatory affairs and cross-functional subject matter experts in developing and executing strategies for organizing and preparing documents for regulatory health authority submissions

+ Coordinate the review and approval of documents

+ Represent Medical Writing to support project sub teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (e.g., timelines and review/revision responsibilities) with members of the project teams and various sub teams

+ Lead the development of templates, style guidelines, and SOPs for clinical documentation

+ Manage/Oversee internal writers or external writing vendors

+ Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements

+ Perform quality control review of medical writing documents

+ Effectively collaborate with Research & Development colleagues, including, but not limited to, clinical research, regulatory, safety, biostatistics, clinical operations, translational medicine, and discovery


+ Minimum requirement of a bachelors degree (advanced degree preferred), with 12+ years of medical writing experience in a pharmaceutical/biotechnology or CRO environment

+ Experience in oncology therapeutic areas

+ Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format

+ Proficient in teamwork, organization, and project management

+ Proficient in MS Office

+ In-depth experience in US and Non-US Regulatory submissions

+ Experience working with cross-functional teams

+ Excellent interpersonal and communication skills

+ Flexible/adaptable in a fast-paced and dynamic work environment

**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link:**

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-07-27 Expires: 2020-09-26

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Director, Medical Writing, San Diego, CA

Kelly Services
San Diego, CA 92108

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