Medical Writer I - BioMarin

Name of Position: Medical Writer I
Number of Openings: 2
Contact Person: Yvonne Gardes
Telephone: (415) 506-3241
E-mail: www.bmrn.com job code(s): 10-0201 / 10-0134
Postal Address: 105 Digital Drive Novato, CA 94949

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

EEO/M/F/D/V

To apply: Visit www.BMRN.com Job Code: 10-0134 or 10-0201

The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

EDUCATION & EXPERIENCE

Bachelor’s or higher degree preferred; scientific focus desirable.
Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.
Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.Up to 2 years as a medical writer in the pharmaceutical industryAt least 5 years of medical or scientific writing experience as a primary job responsibilityClinical StudiesFamiliar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.Familiar with clinical study data collection and results reporting.

Sr Drug Safety Associate/Manager

Position Title: Sr Drug Safety Associate/Manager

PRIMARY PURPOSE OF POSITION: This position will be responsible for the collection, documentation and processing of serious adverse events from clinical trials in accordance with Federal Regulations and the company's Standard Operating Procedures. This position will also be responsible for managing the CRO drug safety functions. This position will be reporting to the Director of Clinical Research (MD).

MAJOR DUTIES OF POSITION:
· Follow case processing management of incoming SAEs from Phase I and II clinical studies through case approval and closure.
· Oversee CRO drug safety functions, CRO personnel, SAE reconciliation, SAE tracking of Phase III clinical trials
· Produce Clinical Safety Queries as needed for clarification of reports.Create and maintain workflow trackers, flow charts as needed
· Serve as a drug safety resource to other departments
· Work closely with medical monitors and interact on a regular basis with clinical operations and regulatory affairs to communicate project status updates.
· Identify process improvement strategies and develop/enhance internal drug safety processes and SOPs
· Draft SAE narratives for review by Medical Monitor KNOWLEDGE AND SKILL REQUIREMENTS:
· PharmD, RN, RPh, BS with at least six years of drug safety experience
· Working knowledge of ICH/GCP Guidelines, MedDRA and WHO_DRUG coding
· Familiarity with safety databases, data entry platforms, adverse event data collection process, 15-day safety alerts, submissions of safety updates to the FDA, BLA/NDA pre-approval process, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development.
· Fluent in medical terminology
· BLA/NDA experience a plus
· Must have decision-making skills
· Positive attitude
· Able to manage own work flow independently
· Be a team player

mailto:raquel@biosearchbay.com
925-516-4323

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

Clinical Safety Associate, Genentech

Job Title: Clinical Safety Associate
Company: Genentech
Status: Full Time
Years of Experience:
Location: South San Francisco, CA

Description:
For over 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs.

The Clinical Safety Associate I (CSA I) is a member of the Drug Safety Department and working within a project team structure. The CSA I is primarily responsible for reviewing routine serious adverse event (SAE) reports from clinical trials (CT) and post marketing spontaneous reports for an assigned project. The CSA I is responsible for completeness and clarity, defining and initiating follow-up through the appropriate channels, participating in the triage of these reports for regulatory reporting purposes and facilitating communication with the Medical Affairs Clinical Team review of individual clinical trial and postmarking SAE reports. Demonstrates basic knowledge of safety concepts, focused on standards set out in ICH and FDA guidelines for drug safety reporting requirements. Demonstrates proficiency in case triage for a project molecule and serves as a back up for additional projects with the appropriate experience per SOPs and project coding guidelines. Appropriately identifies proper case regulatory reporting requirement with assistance from a senior CSA or Scientist. Identifies and utilizes resources and support available for adverse event triage and management. Applies Good Clinical Practices (GCP) documentation of phone, electronic, and/or fax correspondence regarding case follow-up information. Competently initiates and codes cases in the safety database based on SOPs. Identifies pertinent clinical information in adverse event reports and incorporate information in narrative field per standard narrative template. Identifies and enters relevant follow-up information in appropriate data and narrative fields per SOPs. Performs basic searches for data queries within the safety database. Assists in the preparation of expedited reports to regulatory agencies and partner companies including 15-day Alert reports, IND Safety Reports, and Serious, Labeled Expedited Reports. Assists in the preparation of U.S. Periodic Reports and International Periodic Safety Update Reports. Participates in discussions with requesting clinicians/consumers regarding drug safety information with the guidance/support of senior staff. Demonstrates general understanding of purpose of meetings for department, division, and appropriate molecule related projects, and attends as appropriate.

Requirements:
RN, BSN, NP, PA, MSN, RPh, Pharm D, or other applicable Health professional degree preferred. Clinical experience in a Health Care-related field. Previous experience in Clinical Safety or Drug Safety preferred. Computer proficiency in word processing, e-mail, spreadsheet applications, and applications of relational databases preferred. Attentive to detail. Excellent communication and interpersonal skills.

Genentech offers one of the most comprehensive benefits packages in the industry. Our culture emphasizes working hard, collaborating and sharing rewards. Our employees enjoy an environment that supports a work-life balance through benefits and programs that include sabbaticals, near-site childcare and concierge services. You can apply by forwarding your resume to the provided e-mail address. You can also apply by visiting our website at www.gene.com/careers; reference Requisition #1000013261. This will allow you to create an account and store a resume for application to Genentech positions. We are an equal opportunity employer.

Contact Email: genentechinternet@gene.com
Contact Phone: 650-225-1000