Summary: As a member of the Office of Medical Affairs, the Medical Writer with be principally focused on writing and preparing documents and articles for peer reviewed journals in collaboration with physicians and Silk Road Medical colleagues.
This will include clinical content creation including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on Silk Road Medical trials and registries. The Medical Writer will write and edit clinical development documents, including but not limited to, clinical study reports, integrated safety and efficacy summaries, presentation materials and publications to medical journals.
- Performs scientific writing (e.g. abstracts, manuscripts, presentations).
- Primarily focused on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies)
- Participates in post-market surveillance activities by conducting routine systematic literature for specific medical device groups or sub-groups.
- Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.
- Ensures documents are produced in accordance with procedures, internal and external guidelines and electronic templates.
- Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and Silk Road Medical corporate goals.
- Possess expert knowledge of clinical research, device development processes, regulatory requirements, good clinical and data management practices.
- Serve as a scientific liaison to the medical/scientific community responsible for establishing, developing and maintaining peer-to-peer relationships with HCPs on a national level
- Ensure the appropriate dissemination of clinical and scientific information, in a timely, ethical and customer-focused manner; implement scientific and educational strategies in collaboration with colleagues from Medical Affairs and Clinical investigator initiated research, and educational initiatives; work to pair our key customer’s educational and research needs with available resources aligned with strategy, and also provide the latest emerging data in response to specific healthcare professional inquiries.
- Maintain, strengthen and develop new/existing relationships with relevant key clinicians.
- Responsible for adhering to all legal, regulatory and Compliance policies.
Minimum Qualifications, Experience and Skills Required:
- Bachelor’s degree required. Advanced degree preferred.
- Minimum of 5 years of relevant medical writing experience with experience in Cardiovascular Medical Device industry preferred.
- Scientific/clinical background.
- Experience writing CERs.
- Understanding of statistical analysis.
- Must possess a thorough understanding of the FDA, OIG, HIPPA, ADVAMED Code and other ethical guidelines relevant to the medical device industry, to ensure compliance with these external as well as internal guidelines and standard operating procedures.
- Excellent collaboration skills required with the ability to work effectively internal and external peers
- Must demonstrate strong commercial and business acumen
- Must be a self-starter with the ability to work independently and prioritize multiple tasks to meet strict deadlines
- Ability to use a PC with mastery of the Internet, Intranet and Microsoft product (Outlook, Word, Excel, PowerPoint, Access, Project and Photo Editor)
- Ability to quickly learn and master SRM’s specific systems
- Excellent verbal and written communication skills required
- The candidate must be flexible to travel 30% to 40%. Overnight travel, inclusive of workweek and weekends will be required
Interested candidates should submit their resume to email@example.com.