Kelly Services Senior Medical Writer in South San Francisco, California
Senior Medical Writer (Pharmaceutical)– San Francisco, CA
Exciting opportunity for a Senior Medical Writer with a late-stage biopharmaceutical company focused on discovering, developing and commercializing treatments for debilitating diseases.
The Senior Medical Writer will be responsible for collaborating with a number of departments in writing, reviewing and preparing a variety of technical documents, including: protocols/amendments, investigator brochures, consent forms, annual reports, DSURs, final study reports, and sections of INDs and NDAs. While the focus will be in the clinical and regulatory areas, the ability to assist with preparation of CMC documentation and drafts of scientific publications is a strong plus. The Senior Medical Writer will coordinate document preparation with a team of writers
Essential Duties and Responsibilities:
Draft high-quality clinical & regulatory documents that demonstrate a good grasp of the scientific and medical content and drug development process with excellent understanding of data analysis, data management and regulatory submissions.
Work across departments to help set priorities for document preparation and collaborate on document content.
Coordinate and manage consulting writers as needed.
Work with service providers as needed for delivery of high quality documents.
Write clinical abstracts, posters, and manuscripts.
Review and edit documents prepared by other authors.
Maintain document history and manage version control of documents.
Provide guidance for style guides for document preparation.
Keep current with relevant therapeutic area(s).
BS/MS/Ph.D. with minimum of 8 years’ experience working as a Medical Writer in the biotech/pharmaceutical industry.
The ability to critically analyze, synthesize, and present complex information in well-constructed documents.
Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, CTXs, NDAs and MAAs.
Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member.
Ability to coordinate other writers in the preparation of complex submissions.
Experience with Phase I-III clinical trials including international regulatory requirements.
Proficiency with medical terminology and ability to articulate drug development data, process, and regulatory submissions.
Expertise regarding Clinical Study Report (CSR) and appendices.
Experience with event and drug coding dictionaries.
Knowledge and experience with CMC sections of INDs, NDAs, and other submissions is a strong plus.
Skilled with software applications and document management systems, including experience with document templates.
Apply Today! Questions? Call Justin at 714.602.1217 or email your resume to Justin.firstname.lastname@example.org
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm