Regulatory Medical Writer

San Francisco Bay Area

1-year contract, on site, W-2.

Responsibilities 

• Demonstrated clear, high quality scientific writing style in the English language
• Competence in the preparation of a variety of regulatory documents
• Ability to independently analyze and synthesize data from a broad range of disciplines
• Ability to work effectively in a team environment
• Strong communication and organizational skills
• Strong interpersonal skills    
• Excellent knowledge of regulatory documentation guidelines pertinent to subject area, i.e. Clinical/Safety
• Demonstrated leadership skills    
• Commitment to performance measures of time, costs and quality
• Problem solving skills
• Ability to coordinate multiple documents/assignments to tight deadlines
• Demonstrated ability to lead and communicate effectively at all levels 

Requirements

• PhD, MSc or equivalent in a relevant scientific discipline, or healthcare professional
• Previous pharmaceutical experience in Regulatory writing REQUIRED

Contact
 
Please email Lindsey Summers at lsummers(at)ascentsg.com or call at 303-694-5482

PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.

Rockville, MD

Job Summary 

Responsible for coding the data found on sponsor-generated Case Report Forms (paper and electronic CRFs), which include medical history, adverse events, medications, and indications for medications. FULL RELOCATION OFFERED.

Job Duties

• Perform medical coding of all medical terms and medications found on CRFs using standardized terminology (MedDRA and WHO Drug dictionaries)
• Follow HGS Coding guidelines, SOPs, and Working practices
• Generate coding queries for clarification of terms
• Create coding reports and review coded data for quality, accuracy, and consistency within and across clinical protocols.
• Helps updating synonym list and create new synonyms  

Minimum Qualifications

• BA/BS required. Nursing degree strongly preferred.
• 2 - 3 years experience coding events and drugs in the biopharmaceutical industry.
• Experience with Clintrial, and Electronic Data capture system preferred
• Knowledge of GCP and ICH guidelines as applicable to clinical data management
• Must have working knowledge of MedDRA and WHO Drug dictionaries.
• Ability to handle multiple projects and priorities.
• Extreme attention to details.
• Ability to work under pressure and meet deadlines.
• Strong interpersonal and communication skills

Scientific Writer Preclinical Development

Tarrytown, NY

Regeneron Pharmaceuticals
 
Req Number: 1831; Development Division
 
Description
 
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer.

Specific plans and justifications:  Full-time employee in the Preclinical Development and Protein Science group to author various reports and regulatory documents in support of all preclinical development programs, including INDs, Investigator Brochures, FDA Briefing Packages, sample analysis reports, pharmacokinetic and toxicokinetic reports, and other written documents, as determined by management.
 
Experience
 

Experienced preclinical drug development scientist with strong and documented written and verbal communication skills needed for full-time position in the Preclinical Development and Protein Science group. The incumbent will independently author Pharmacokinetic Written Summaries and Nonclinical Overviews in support of IND and BLA submissions for biotechnology-derived drugs. Responsibilities will also include contributing nonclinical PK and TK sections for IBs and FDA Briefing Packages as well as independently interpreting data from nonclinical PK and TK studies and authoring the associated, IND or BLA-supporting reports.

The ideal candidate will hold a PhD degree in pharmacokinetics, pharmaceutics, pharmacology, or toxicology and will have at least 3 years of experience providing nonclinical PK and TK support on cross-functional drug development teams within a pharmaceutical company. Ability to independently author the associated sections of regulatory submissions and supporting study reports is a must. Candidates with an MS degree and demonstrated, strong written and verbal communication skills with at least 8 years of relevant experience providing nonclinical PK or TK support on drug development teams will also be considered. Computer proficiency (Word, Excel, Adobe and related software) and fluency in the English language is required and WinNonLin experience is highly desirable. The hiring level is commensurate with experience.

Contact

If interested, email Jessica Matthews at jessica.matthews@regeneron.com.

Associate Director, Medical Communications

Pennsylvania

MD or PhD with at least 5 years of healthcare research experience

Background experience and understanding of:

• The Healthcare System, Health Policy Issues & Technology Adoption Issue
• Business Intelligence - to perform daily operations managing and expanding the health technology assessment service 

Interpersonal attributes: must be an analytical and critical thinker 

Experience managing direct reports, budget planning; ability to implement business plans

Knowledge of sales and marketing functions preferred

Manage the development and quality of the health technology assessment service

Produce evidence reports for healthcare technology, procedures and processes

Interact with external customers and cross-functionally within the organization 

Contact 

Please send resumes to sorrem2@kellyservices.com.

Medical Writer

Swiftwater, PA Area

The candidate must:

• Have solid experience in protocol and study report writing (experienced!!)
• Need little to no oversight
• Vaccine knowledge or experience in writing about vaccines
• Be available full time

If the candidate speaks French - that would be even better!

Could possibly work from home and commute to the office a couple of times per week, depending on the individual.

Contract Medical Writer

Maryland