Medical Writer

Job Title: Medical Writer
Company: XenoPort, Inc
Status: Full Time
Years of Experience: 8+
Location: Santa Clara, CA
Description:
We are currently seeking an individual to become a member of our growing team in providing expertise with developing, writing, reviewing, and editing clinical development documents, including but not limited to clinical protocols, Investigator Brochures, clinical study reports (full report and synopses), subject consent forms, abstracts, and publications to medical journals through collaboration with clinical researchers and regulatory scientists.

Responsibilities:
·Integrate various sources of scientific information into a uniform style and language for regulatory compliance.·Coordinate internal review and QC of documents as well as with CROs and business partners.·Support the PI, Regulatory Affairs and other collaborators in the development of sections for initial IND submissions (CMC, Pharmacology/Toxicology) and IND Annual Reports.·Compose abstracts, manuscripts, and power point slides from source data output provided by researchers for presentations and publications in scientific journals.·When lead clinical development program advances to registration, work with partners, researchers, and project managers to develop an NDA consistent with FDA/ICH norm for worldwide registrations.·Strengthen the efficiency of the company internal document management system for audit and document record keeping purpose. Qualifications and Other Required Knowledge and Skills:·A Masters/PhD degree from an accredited college or university in biological/biomedical science, or equivalent experience is required. ·Minimum of 8 years experience in a pharmaceutical, biotechnology and/or clinical environment including a minimum of 3 years medical and regulatory technical writing/editing.·Must be able to function independently with minimal guidance and/or collaboratively within a team setting.·Demonstrate highly effective problem-solving, planning and organizational skills.·Effectively communicate both verbally and in writing with demonstrated expertise with grammar, syntax, and format.·Demonstrated ability to write and edit clear, concise clinical document compliant with FDA and ICH guidelines, as well as all practices and procedures related to medical writing.·Proficiency in word processing systems, i.e., Microsoft Word, MS Office or similar systems.·Must be familiar with document management systems and up-to-date on regulations such as FDA, CHMP (EU), ICH guidelines and current good clinical practices.·Must have experience and significant participation in preparation of clinical documents for regulatory submissions (e.g., clinical protocols, INDs).

Contact Information:
Contact Name: Human Resources
Contact Email: jobs@xenoport.com
Contact Phone: 408.616.7200

Sr Manager, Medical Information & Publicatication

Job Title: Sr Manager, Medical Information & Publicatication
Company: Confidential
Status: Full Time
Years of Experience: 3+
Location: Napa Valley, CA
Description:
Key functions of this position will include but not limit the responds to daily medical information requests from the professional community, patients, and internal colleagues, organize, support and enlist help from the medical community to create relevant and timely articles, abstracts, presentations,and posters that will provide balanced and fair, scientific and relevant medical/product information.The candidate who will contribute to the overall success of sales by providing scientific evidence to support sales of products. The successful publication launch of Cyanokit will be in part this person's key responsibility the first 6 months and will include but not limited to responds to daily medical information requests.

ESSENTIAL FUNCTION & RESPONSIBILITIES:
1. This position will be responsible for providing information i.e. analytical as well as monthly reports, presentations, (verbal and written) on marketed products and compounds to external customers (health care professionals, patients) and internal employees (medical liaisons, sales representatives, international offices, etc.)
2. Work in a cross-functional environment that includes routine collaboration (evaluating data, making presentations) with staff members from Medical Affairs, Clinical Research, Sales & Marketing, Quality Systems, Regulatory Affairs, Drug Safety, and other departments within the company
3. Review and edit medical information to ensure compliance with legal and regulatory standards before conveying to external customers (complete and fair-balanced)
4. Participate in weekly and other necessary staff meetings per department guidelines and assist as a team member in the review, up dating and creation of standard operating procedures/policies

REQUIREMENTS: PharmD or R.Ph, with Medical Publications and Drug nformation background of at least 3-5 years and comparable level of job expertize or requirements sucessfully completed at the last place of employment.

Contact Information:
Contact Name: Kendra KhawajaContact Email: kendrak@nsasearch.com
Contact Phone: (760) 268-0377

Sr Director, Medical Affairs & Clinical Research

Job Title: Sr Director, Medical Affairs & Clinical Research
Company: Confidential
Status: Full Time
Years of Experience: 6+Location: Napa Valley, CA
Description:
This position has overall responsibility for Pharmacovigilance, drug information, drug safety and clinical study protocols development. Oversees the direction, planning, execution and interpretation of safety data from clinical trials/research, safety data collection activities. Establishes and approves scientific methods for design of clinical protocols. Supports new and ongoing clinical research and clinical trials. Selects and interacts with CROs and other vendors.
-Directs activities of multiple functions focused on providing medical information to staff and outside healthcare professionals.-Responsible for providing medical input and consultation to address medical and drug safety issues on commercial products.
-Designs, develops, implement and oversees policies and procedures to assure meeting regulatory timelines for monitoring and reporting drug safety/Pharmacovigilance.
-Directs and manages Pharmacovigilence activities.-Directs and manages medical education and CME programs.
-Reviews unrestricted grant requests and coordinates Investigator initiated trials.
-Directs the designing and oversees the administration of clinical study protocols.
-Participates in the selection of clinical CRO.-Acts as spokesperson on medical and clinical issues.
-Oversees and/or participates in discussions with FDA and other regulatory agencies on medical and drug safety issues.
-Provides medical and clinical reviews for potential in-licensing candidates.
-Responds to medical and clinical inquiries on products from outside groups, physicians, agencies, etc.
-Lead company contact with FDA and other health authorities on drug safety and medical information.
-Directs and takes a leadership role in the design, modification, development and implementation of company practices and policies that affect drug safety and drug information.-Responds to requests for medical/drug information, both from internal and external customers.
-Takes a leadership role in the development of new products.-Directs and manages Adverse Effect (AEs) reporting to FDA and MGG.-Serves as a member of NPC.
-Provides medical education to MSLs and Sales & Marketing staff.
-Presents medical information on products at meetings with various state and Federal agencies and therapeutic committees.

Requirements:
MD, PharmD, or PhD from a U.S. recognized program. Training and experience in Drug Information and Pharmacovigilance. Training and experience in designing of clinical trials for the development of new drugs or dosage forms. Requires previous management and project experience.

Contact Information:
Contact Name: Kendra KhawajaContact Email: kendrak@nsasearch.com
Contact Phone: (760) 268-0377