Senior Medical Writer
4300 Hacienda Dr Pleasanton, CA 94588
Bayside Solutions is seeking a Senior Medical Writer to be part of our client’ s team in the Tri Valley. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com
Sr. Medical Writer
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- The Senior Medical Writer is an integral member of the clients Medical Writing team whose primary focus includes technical writing support for the following Clincal Study documents: Clinical Validation Plans, Intended Use Statements, Protocols, Clinical Study Reports, Instructions for Use and/or Package Inserts, Medical Opinion Document
- In addition, this position would be expected to work with Medical Affairs to offer technical writing support for the
- following scientific communications: Scientific Posters, Literature Reviews, Scientific Manuscripts
- This position reports to the Medical Writing Manager. Scientific focus areas for the group include
- Infectious Diseases and Oncology. Technological focus areas include PCR and Sequencing.
- Communications Project Manager and responsibilities may include interfacing with authors, journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, and electronic consolidation of submission documents.
- Supports development of scientific posters including the printing and delivery for scientific presentations, in partnership with the Medical Writing team and/or other internal/ external SMEs
- Acts as a mentor to less experienced members of the Medical Writing team; is committed to others and own professional development; and exhibits skills of agility, effective decision-making, adaptability to change and influencing without authority.
- The Essential Responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. This position may be required to perform additional duties as required.
- Doctoral degree (e.g., PhD, PharmD etc) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, or other related/ relevant fields
- English as a primary language
- > 3 years scientific research and/or medical writing experience in academic settings or pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports.
- Understanding of regulatory and audit requirements for diagnostics and/or pharmaceuticals with experience working on submissions for new applications to the U.S. Food and Drug Administration (FDA).
- Excellent project management skills and ability to drive several high-impact projects simultaneously
- Submission and publication management of scientific manuscripts to at least 5 different journals
- 5 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports.
- Supervisory and/or project management experience
- Submission and publication management of scientific manuscripts to at least 10 different journals
- Experience with in vitro diagnostics, molecular diagnostics and/or Infectious Disease
- Knowledge of different aspects of assay development (e.g., biostatistics, nonclinical and clinical research)
- Travel: On-site presence required with minimal travel requirements. Occasional domestic travel to select conferences or internal meetings.