www.inkthinkerblog.com — I was recently contacted with some jobs that aren’t a good fit for me, but they might be just what you’re looking for! I’ve spoken with the hiring organization and they are excited to consider qualified Inkthinker readers. Please tell them Kristen King sent you.
Position 1: Medical Writer (Gaithersburg, MD)
Biopharmaceutical company and company, willing to pay relocation.
Position Summary:
Major Duties and Responsibilities:
· Under general supervision, writes first draft of, or edits, manuscripts, review articles, abstracts, posters, and meeting presentations.
· Gathers information for journal selection and formats publication per journal’s requirements.
· Reviews relevant medical/scientific literature for publication development and for research trends.
· Participates in maintaining a database of references across therapeutic areas of interest based on literature review.
· Participates in the creation of timelines and status reports for document review cycle.
· Manages the review cycle of documents from first draft through final approval, including review by both internal company team members and external investigators; edits documents based on comments.
· Ensures the quality of scientific publications by maintaining and promoting familiarity with ICMJE, AMA, and other standards.
· Participates in publication update and publication planning meetings.
Requirements/Qualifications:
Education:
· Requires a bachelor’s degree in a scientific discipline, and an advanced degree in a scientific discipline or equivalent work experience.
Experience:
· 2-4 years biopharmaceutical industry experience, including 1-2 years experience writing publications.
· Background in biologics such as monoclonal antibodies and immunology or in inflammatory diseases and oncology is a plus.
Special Skills/Abilities:
· Experience writing and editing scientific—preferably clinical research—manuscripts for peer-reviewed journals, meeting abstracts, and scientific review papers.
· Familiarity with ICMJE, AMA, and other standards; evidence of professional development in medical writing or editing (such as AMWA or BELS certification) a plus.
· Ability to analyze critically and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
· Excellent writing, editing, attention to detail, and verbal communication skills.
· Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) essential.
· Skill in using medical/scientific computer databases to search and collect information.
· Knowledge of reference and bibliographic software and creation of reference databases.
· Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment.
Position 2: Regulatory Affairs Director (Wayne, PA)
Pharmaceutical company. Company will pay relocation.
Job Title
Regulatory Affairs Director
Job Summary
Under the direction of the Senior Director, Global Regulatory Affairs, the Regulatory Affairs Director is responsible for developing and directing objectives, policies and programs pertaining to development and marketing of U.S drug products.
Responsibilities
· Designs and implements regulatory strategies to obtain, maintain and extend product registrations.
· Provides regulatory guidance and input to project teams.
· Oversees the creation and submission of Regulatory documents, e.g., INDs, NDAs., supplemental NDAs and other relevant regulatory filings.
· Serves as corporate liaison with regulatory agencies to develop effective professional relationships as well as our positive company image.
· Provides guidance to all appropriate departments in SPD and other operating companies to assure compliance with applicable regulations.
· Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
· Arranges for and leads meetings with global health authorities as needed.
· Provides training and mentorship to regulatory staff and other staff.
· Makes recommendations for regulatory department operating procedures.
· May be responsible for creating and reviewing SOPs as needed.
· May supervise a changing number of Regulatory Affairs staff
Education & Experience Requirements
· M.S. or Ph.D. in a scientific field is strongly preferred
· A minimum of 7 years of Regulatory Affairs or related pharmaceutical experience
· At least 3 years of management experience; or an equivalent combination of education and experience.
Key Skills and Competencies
· Expertise to effectively communicate, interact and negotiate with regulatory authorities.
- Expertise to independently present complex information to senior management, consultants, regulatory authorities and the medical community.
- Expertise to independently resolve problems and identify areas of opportunity.
- Expertise to write scientific and technical documents
- Expertise to lead and influence regulatory and cross-functional teams.
- Proven ability/expertise to provide a strategic vision for regulatory strategy across therapeutic areas
- Expertise to create, establish and communicate both local and global regulatory strategy
- Expertise in regulatory submission structure and content (NDS, NDA, MAA)
- Must have a level of expertise in each of these areas and expertise in a subset:
- drug development knowledge and expertise (Preclinical, Clinical, PK)
- reviewing promotional materials and negotiating changes with the agency
- identifying and implementing changes in product labeling
- Proven ability/expertise to motivate, mentor and manage a team
- Proven ability /expertise to develop and share best practices within Regulatory Affairs and with other functions
- Proven ability /expertise to support regulatory standards and philosophy
- Strong organizational skills, attention to detail, ability to multi-task, and MS Office ability.
Other Job Components
Global regulatory strategy; personnel hiring and deployment decisions; budget input; defining strategic priorities
Internal and External Contacts
Advises and consults with: PST members, BU representatives, R&D functional representatives, Legal, Finance, Program Management, Human Resources.
Other Requirements
10-20% travel overall – some international required
Position 3: Manager of Regulatory Operations (Rockville, MD)
Pharmaceutical company in Rockville, MD. Company will pay relocation. Position is prob. 60% medical writing, 40% regulatory)
Job Title : Manager
Department : Regulatory Operations
Reports to : Vice President, Clinical Development
Description:
- Principle activity will be the organization and formatting of regulatory filings in CTD format
- Work closely with CROs and internal Pre-Clinical, Clinical, Manufacturing and QA staff in the coordination and preparation of documentation to support regulatory filings
- Advise teams on the timelines and process for regulatory submissions publishing
- Write, revise, and format preclinical and clinical documents for submission to global regulatory agencies
- Prepare and maintain submission tracking documents and monitor status of submission components
- Maintain up-to-date knowledge of FDA standards and procedures for regulatory submissions, including eCTD; analyze new and revised guidances, advise management of new requirements
- Drive improvements in corporate document templates and Style Guide
- Evaluate and implement company regulatory publishing systems/mechanisms, document management system and regulatory software tools and templates
Requirements:
- Bachelors degree in scientific discipline (Graduate degree desirable)
- Medical writing experience in established pharmaceutical company or CRO of 8 or more years
- Experience in the coordination and filing of regulatory documents including CTAs, INDs and NDAs, in the CTD format. Experience with eCTD a plus
- Expertise in Word and in editorial and publication software programs
- Highly organized and able to effectively multi-task; strong project management skills
- Possess excellent communication and negotiation skills
TO APPLY:
Contact Laci Williamson at Precept Life Sciences, 703-663-1066 or lwilliamson@preceptlife.com. Please tell her Kristen King from Inkthinker sent you.
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