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Medical Writing/Regulatory

Last updated: 10:01 05/03/2013

Medical Writer

Reference number: 2004 Apply for this job Apply for this job »
Type: Contract, part time Location: Office based in Ely, UK

Job Description

Salary and Benefits:                       £25k to £30k. For more senior candidates consideration will be given to a salary in the range £30k to £35k.

 Benefits are after 6 months probation period:   Company pension scheme (company 5% employee 3%), Private Medical Insurance, Life Assurance, Medical Benefit scheme. 

 A Childcare Voucher scheme is also in operation.

 
   Summary:

The primary function of this position is to prepare high-quality biomedical communications for the company’s clients, on time and within budget. In this role, the Medical Writer will work closely with other departments within the company and with the company’s clients.

 The Role:

 § Act as primary contact both within the company and with the client for specific projects.

§ Preparation of high-quality biomedical communications that meet the client’s goals in terms of content and timescales.

§ Involvement at all stages of the communications process, from preparation of the writer’s brief, through data/information review, writing and editing, to publication.

§ Liaise with the client, if necessary, to ensure that all resources necessary for a biomedical communications project are available and be receptive to the client’s requests.

§ Maintain up-to-date knowledge of key therapeutic areas.

§ Maintain up-to-date knowledge of new communications media.

§ To perform other reasonable tasks as requested by the company’s senior management staff.

Experience/Qualifications required

Skills and Attributes:

 § Excellent written and oral skills.

§ Excellent accuracy and attention to detail.

§ Good knowledge of Microsoft Word, Excel, Outlook and PowerPoint, and internet search methods.

§ Good organisational and interpersonal skills.

§ Ability to work alone or within a team.

§ Ability to manage competing priorities in a changeable environment.

§ Ability to work to tight deadlines.

 Experience:

 § A minimum of 2 years of medical writing experience gained within a communications agency or the pharmaceutical or healthcare industries.

§ A minimum of 2 years of experience of reviewing work and/or coaching.

 Qualifications:

 § Qualified to at least degree level in a life sciences subject.

Senior Manager, Medical Writing

Reference number: 2002 Apply for this job Apply for this job »
Type: Permanent, full time Location: Marlowe, Office based

Job Description

Summary:

Author regulatory documents for clinical research, including clinical study reports, clinical sections of common technical documents, investigator brochures, protocols, and other clinical documents.  As a lead writer, track and prioritise team writing projects, contribute to regulatory strategy, and coordinate efforts of contributing writers with oversight of senior staff.  Provide medical writing input into clinical development processes, templates, and SOPs.

The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organisation.  Other activities, special projects and assignments may be given as required.  As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organisation as a whole.

Leads the medical writing team to maintain focus on quality medical writing deliverables against defined project timelines and priorities.

The employee must conduct his/her work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all company policies, and procedures. Company policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives

 The Role:

 Clinical Document Preparer

Prepares clinical study reports for phase 1, 2, and 3 clinical research studies in support of regulatory submission of drugs and biologics worldwide.  Acts as the lead writer for key clinical study reports, clinical trial protocols, investigator brochures, and other clinical documents.  Coordinates compilation of required attachments and appendices, and oversees review and final publication.  Works with all contributing departments to ensure that all necessary information is organised and summarised effectively.  Ensures that clinical study reports accurately reflect study results and coincide with R&D strategies and regulatory requirements.  Tracks, prioritises, and manages team writing projects.

 CTD Author/

Manager

Serves as lead writer on regulatory filings and other large medical writing projects.  Develops the format and writes the content of clinical sections of common technical documents, and coordinates the review and final publication of these sections.  Serves as a core product team member, contributes to regulatory strategy, and develops working time lines.  Organises and manages other medical writing aspects of the CTD, including the coordination of efforts of contributing writers.

 Leadership and People Development

 Responsible for the role which includes providing leadership, support, and influence to ensure timely and quality deliverables. Hire, train and manage performance of staff (inclusive of orientation, personal development, completing and administering performance evaluations, reward and recognition). Works closely with Human Resources and/or temporary staffing/contract agencies to ensure timely hiring of qualified resources. Actively promotes empowerment and accountability.

 General Compliance and Other Role

The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as the company’s policies, SOPs and Work Instructions.  Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.

  

Experience/Qualifications required

Skills and Attributes:

 Role Name

Proficiency

Clinical Document Preparer

Highly Skilled

CTD Author/Manager

Highly Skilled

Leadership and People Development

Highly Skilled

 Essential Skills

Proficiency

Cross Functional Relationships

Highly Skilled

Communication Skills

Highly Skilled

Decision Making

Highly Skilled

Execution/Results/Process Improvement

Highly Skilled

Customer Satisfaction

Highly Skilled

 ·         Excellent medical writing skills with ability to analyse and interpret clinical and scientific information and to summarise findings in an objective and concise manner.

·         Excellent planning, organisation, and troubleshooting skills

·         Able to manage multiple medical writing projects that have aggressive time lines with minimal oversight from senior staff.

·         Able to supervise other medical writers, both in-house and contract

·         Proven ability to work independently and effectively in teams

·         Effectively demonstrate leadership and motivational skills

·         Excellent computer skills, including familiarity with document management and publishing systems.

·         Ability to travel 10% of the time.

 Experience:

 ·         Significant and substantial experience in medical writing including  planning, organising, and writing all aspects of the clinical portions of NDA/BLA/MAA submissions from a medical writing perspective in the pharmaceutical industry. 

·         Hands on experience of successfully supervising medical writers in the pharmaceutical industry. 

 Qualifications:

 ·         A bachelor’s degree in a health care, biological sciences, biostatistics, or related field (or equivalent experience), a master’s degree in these fields (or equivalent experience) or a PhD/MD in these fields (or equivalent experience).

·         An advanced degree as well as familiarity with clinical research, biostatistics, and US and European Community regulations relevant to Clinical Development in the pharmaceutical industry is highly desirable.

·         Knowledgeable of US and European regulatory guidelines related to clinical development and regulatory marketing applications

Senior Medical Writer

Reference number: 1967 Apply for this job Apply for this job »
Type: Permanent, full time Location: London, Possibility of some home based

Job Description

Summary:

 The successful candidate needs to be able to consistently produce high quality materials for the pharmaceutical industry and other medical bodies. Global and national travel will be a requirement for this role.

 The Role:

 Researching and developing a range of medical education and communications materials, including meeting outputs, slide kits, posters, oral presentations, multimedia and scientific publications

  • Liaising with clients in the pharmaceutical industry and key opinion leaders
  • Preparing for scientific meetings and providing onsite support
  • Managing projects within their specifications to budget and agreed timelines

 Overall Responsibility

 

  • To perform project orientated tasks according to the brief agreed by our client and its clients, according to the specifications and timelines agreed
  • Tasks will involve medical and scientific writing, reviewing and editing of documents, medical communication plans, slide development and reviews, conference summaries and write-ups, internal document development, internal policy development, scientific and strategic input and liaison with clients and external experts

 Internal Responsibilities

 

  • Manage each assigned project, keeping the client and team informed as to the progress of the project
  • Strategic and scientific input in meetings and project development
  • Manage and plan projects in line with agreed budgets
  • Management and development of product communication plans
  • Review and edit documents developed for internal and external use
  • Develop medical and clinical training materials
  • Work with other team members to agree timelines and project plans
  • Support and mentor junior members of staff
  • Manage and oversee the work of junior members of staff and develop performance plans for staff in accordance with company and personal objectives
  • Manage, develop and maintain project budgets where appropriate

Experience/Qualifications required

Experience:

 

At least 5 years’ experience in medical communications.

Senior Regulatory Affairs Specialist

Reference number: 1932 Apply for this job Apply for this job »
Type: Permanent, full time Location: Nottingham or London

Job Description

Summary:

 The Senior Regulatory Affairs Specialist provides project representation and regulatory management for all stages of the drug development cycle.

 The Role:

Tasks may include:

  • Liaise with the Regulatory Affairs Manager/Regulatory Affairs Director to plan, organise, compile, progress and submit regulatory submissions on a timely basis
  • Coordinate and manage regulatory and ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
  • Provide advice on appropriate regulatory strategies
  • Stay abreast of changing regulatory legislative requirements and maintain regulatory intelligence database
  • Contribute towards the preparation of technical reports, which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissions.
  • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc., to ensure compliance with ICH GCP and country specific requirements
  • Effectively communicate status of submissions with the Sponsor, Head of Regulatory Affairs, Project Manager, CRAs, Medical and Scientific Affairs staff.
  • Comply with SOPs, ICH GCP and national regulations as applicable
  • Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
  • Deputise for the Regulatory Affairs Manager/Director as required 

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Experience/Qualifications required

Skills:

 

  • Clearly, proven organisational management skills are essential attributes
  • Strong planning, strategising, managing, monitoring, scheduling, and critiquing skills
  • Excellent written and verbal communication skills to clearly and concisely present information
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Ability to exercise sound judgment and make decisions independently
  • Excellent self-motivation skills
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint   
  • Good knowledge of ICH GCP
  • Good knowledge of EU Clinical Trials Directive

 Experience:

 Previous experience within the pharmaceutical/CRO industry.

 Qualifications:

 Bachelor's Degree in Chemistry or Life Sciences, nursing or equivalent experience.

 Contact:

For more information or to make an application, please contact Philip North at NorthWise Services, as follows:

Telephone: +44 (0) 1795 411 571