ISMPP Job Board
April, 2015 Listings

Please take a moment to scroll through the exciting employment opportunities listed here this month.  Or click on the links below to view the individual positions that catch your eye.

If interested in placing an ad on the ISMPP Job Board, click here to view the ISMPP Job Board program options and submit your ad to the ISMPP Office.  If you have additional questions or require assistance, please contact jobs@ismpp.org or call +1 914 618 4453.


Account Director
Account Director/Client Service Director
Account Manager, Publications
Associate Director, Medical Publications
Director, Certification Program
Global Publication Lead
Medical Copy Editor
Medical Publication Lead Neurology & Immunology
Medical Publication Manager Oncology/Immuno-Oncology
Medical Publication Manager Immunology
Medical Writer
Medical Writer
Medical Writer
Publication Manager, Hematology
Regulatory / Scientific Communications Medical Writer
Senior Medical Writer
US Publications Lead


Position: Account Director
Company: MedThink
Location: Raleigh, NC

MedThink SciCom, a full-service, globally oriented and integrated healthcare communications agency, is transforming scientific exchange by uniting a unique array of disciplines to provide novel insights and innovative ideas. There are many ways to communicate science, but MedThink SciCom has a unique talent for taking biomedical information and transforming it into medically relevant and intriguing communications. We are seeking an Account Director who wants to lead this transformation. Responsibilities and requirements include

JOB DESCRIPTION:

Client management:

  • Ensures that the resources of the agency, department by department, are deployed with continued maximum effectiveness in line with the client’s best interest

  • Ensures projects are developed with high quality, on time and within budget

  • Contributes to the development of strategic communication (publication, advocacy development, and medical communication) plans

  • Frequently meets with client (in person or via phone) regarding projects and client direction

  • Oversees budgeting process

  • Controls costs, such as account handling expenses and write-offs in account services


Scientific and design output:

  • Reviews and approves client/brand backgrounder prior to project kickoff meeting

  • Reviews and approves briefing document and all content created

  • Ultimately responsible for ensuring that creative and scientific output is on strategy, on message, and clearly exceeds the client’s expectations

  • Organic growth/Agency Management

  • Anticipates and meets client’s needs

  • Provides recommendations to improve the agency or better customize services to meet client’s needs

  • Develops proposals

  • As time permits, actively identifies and follows up on organic growth and new business leads


Knowledge, Skills, and Abilities:

  • In-depth knowledge of pharmaceutical and agency industry

  • Thorough understanding of communications planning and branding

  • Understanding of the science behind the disease and product in order to contribute and understand client direction

  • Comprehensive understanding of client strategic business plans

  • Superior oral and written communications skills

  • Excellent presentation, organizational, and interpersonal skills 

  • Strong analytical and problem solving skills

  • Ability to motivate others and provide clear direction 

  • Good financial awareness and an ability to manage profitable accounts and increase business within existing accounts

EDUCATION AND EXPERIENCE:

  • Bachelor degree (minimum), preferably in the health sciences or communications field; advanced degree or allied health degree a plus (PharmD, BSN, PhD, MS)

  • 10 - 15 years of pharmaceutical and/or agency experience

  • Certified as a medical publication professional (ISMPP CMPP™) 

  • Prior supervisory experience and the ability to motivate others to attain goals 

  • Demonstrated leadership skills, both within the agency and with clients

 

For full job description and to apply directly: https://medthinkscicom.theresumator.com/apply/owMZBi/Account-Director.htm

 

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Position: Account Director/Client Service Director
Company: McCann Complete Medical
Location: Chicago, IL

Complete HealthVizion, part of McCann Complete Medical, Inc., is a global, award-winning, fresh-thinking medical communications agency based in Chicago’s Magnificent Mile and the UK. We work with global and domestic teams from many leading pharmaceutical and biotechnology companies to educate medical professionals around the world.

We have a great opportunity available for an Account Director/Client Service Director who will be based in our Chicago office.  Our ideal Director will thrive in our fast paced and creative environment ensuring overall client service and financial delivery of business while providing strategic guidance to clients and to internal account teams. In addition, they will be expected to proactively identify and secure new business with senior colleagues to further expand our client base.

Candidates with experience in the medical communication agencies are encouraged to apply. We are actively interviewing!

JOB DESCRIPTION:

 

As part of the Complete HealthVizion team you will:

  • Ensure the delivery of medical communications deliverables while challenging clients to engage with new and innovative solutions

  • Provide strategic leadership of account teams Ensures budgets and timescales are met and Key Performance Indicators are achieved

  • Contribute to accounts through hands-on management of the client and, where appropriate, liaison with external experts

  • Ensure project teams are focused and motivated to deliver high quality and timely work to clients

 

 

QUALIFICATIONS & EDUCATION:

Requirements:

  • Undergraduate degree required, advanced degree preferred

  • Solid commercial background in a medical communication agency

  • Pharmaceutical experience a plus

  • Proven track record of building successful client relationships and winning new business

  • Strong ability to manage multiple clients and projects simultaneously

  • Ability to establish lasting business relationships

  • Strong communication (listening, speaking, writing) skills with internal and external partners

  • Expert time manager and ability to prioritize workload

  • Flexibility and willingness to travel to current client offices

 

 

In return we offer an excellent remuneration and benefits package which includes Medical, Dental, Vision, 401(K) with a Company match, Employee Stock Purchase Plan, Health Care Spending Account, Dependent Spending Account, Transit Program, Paid Time Off, 10+ holidays per calendar year, Parental Leave and more. Our highly skilled teams reflect our continuing commitment to being an employer of choice as well as a provider of choice.

 

If you are passionate and enthusiastic about excelling at your career and want to make a real impact, then this opportunity could be just right for you!

Please visit Complete Group Career site for more information

 

 

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Position: Account Manager, Publications
Company: Peloton Advantage, LLC
Location: Parsippany, NJ

Peloton Advantage, LLC, is a fast-growing medical communications company located in Parsippany, New Jersey. We are a group of talented publication professionals that strive to deliver the highest quality projects to our clients. If you excel in a collaborative team environment and enjoy being rewarded for stellar performance, we encourage you to apply to our company. We are seeking a publication planning experienced account manager to join our team to lead the daily activities of large-scale strategic publication plans.This is a hands-on detail-orientated position that provides an excellent opportunity for growth and advancement.

Qualified candidates can view a full job description, and apply for the position, via this LINK

No recruiters.

 

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Position: Associate Director, Medical Publications 
Company: Boehringer Ingelheim
Location: Ridgefield, CT

Provide strategic direction, lead and manage the development and timely delivery of all medical and scientific publications in support of BI's compounds in the Cardiovascular Therapeutic Area. Incumbent responsibilities include: developing, monitoring and executing a Strategic Publication Plan; maintaining regular interface with Clinical Development & Medical Affairs stakeholders, Medical Publication agencies, and scientific/medical experts; and oversee monitor, facilitate and execute timely publications in alignment with the Strategic Publication Plan.

JOB DESCRIPTION:

Publications Planning: The AD, Medical Publications will be responsible for facilitating the entire BIPI process for developing, monitoring, and executing the Strategic Publication Plan. This will include the following:

 

  • Coordinate and lead Strategic Publication Team meetings to develop 3-year publication strategies and objectives 

  • Serve as primary interface between BI U.S. publications and Corporate publications to ensure that BIPI needs are represented Globally

  • Seek input from key BIPI & BI Clinical Development & Medical Affairs stakeholders regarding development and execution of the 3-year strategic publication plan

  • Seek input from select Scientific Experts regarding development and execution of the 3-year strategic publication plan

  • Ensure scientific strategic direction and goals are reflected in the publication plan along with consensus from Strategic & Tactical Publication Team members

 

 

Executing:

  • Lead and facilitate all Tactical Publication Team meetings

  • Review manuscripts in preparation to ensure, medical accuracy, adherence to ICMJE and related external principles, and conformity to internal publication policies, and the strategic publication plan 

  • Oversee the entire development of individual publications; master timeline and budget process 

  • Author (Scientific Expert) Interactions: 

  • Associate Director, Medical Publications will be responsible for developing and maintaining relationships with Authors/Scientific Experts at a level consistent with the needs for the development and execution of strategic and tactical publication plans.

 

 

Requirements:

  • Advanced Degree in medical science - Scientific/Clinical (therapeutic area specific preferred) 

  • Strong experience working with Scientific Experts/Authors leading high level initiatives.

  • Minimum of three (3) years of publication planning, writing, and/or editorial experience in the pharmaceutical industry (or Medical Education Agency experience).

  • For Masters degree: minimum seven (7) years Medical Publication experience, four (4) of which include relevant therapeutic area experience. Bachelors¿ degree: minimum ten (10) years Medical Publication experience, seven (7) of which include relevant therapeutic area experience

  • CMPP certification not necessary, but desirable.

  • Experience leading projects is required.

  • Understanding of internal and external guidelines, including those related to publications, including 

  • FDA Guidance on Industry-Supported Scientific and Educational Activities.

  • Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (International Committee of Medical Journal Editors [ICMJE]).

  • Principles on the Conduct of Clinical Trials and Communicating of Clinical Trial Results.

  • Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registrations and Databases.

  • The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials.

  • The EQUATOR (Enhancing the QUAlity and Transparency Of Health Research) Network.

  • Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers.

 

 

If, interested, please apply on the Boehringer website.

 

 

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Position: Director, Certification Program
Company: ISMPP
Location: virtual office

The ISMPP Director, Certification Program is responsible for overseeing the ISMPP Certified Medical Publication Professional (CMPP™) Certification Program.

JOB DESCRIPTION:

Specific responsibilities include:

  • Direct all activities associated with the ISMPP Certification Program including, but not limited to, certification exam, recertification program and implementation, certification-related US, European, and other regional ISMPP meeting activities, marketing of Certification Program

  • Represent Certification Program to other related organizations and conferences

  • Contribute to functions of the ISMPP Office by advising on certification-related matters

  • Manage ISMPP relationship with and supervise performance of CMPP testing vendor(s)

  • Provide information on the Certification Program to the ISMPP Board of Trustees as requested

  • Serve as a non-voting Director on the Certification Board

  • Provide overall guidance on the ISMPP Certification Program to the Certification Board

  • Ensure that Certification Board activities adhere to ISMPP bylaws and policies

  • Manage yearly ISMPP Certification Board elections (CMPP Board Nominating Committee)

  • Work with Certification Board Directors in guiding related ISMPP committees (eg, Credentialing Committee, Recertification Committee)

  • Manage the Certification Program annual budget in collaboration with the ISMPP Treasurer

QUALIFICATIONS AND EDUCATION:

Minimum requirements: At least a bachelor's degree and 8–10 years of experience in medical publications/communications, with experience in developing and managing publication plans, proposals/pitches, and industry–agency interaction/management. Experience in managing budgets, vendors, and working groups. Thorough knowledge of current regulations, guidelines, and compliance policies relating to medical publications required. Proficiency with Microsoft Office suite and demonstrated success in working independently within a virtual office environment are essential. ISMPP Certified Medical Publication Professional™ credential required.

Employment type: Part-time (28 hours per week); FLSA exempt status
Reports To: ISMPP President/COO
Location: Home-office based, 10% travel expected
Direct reports: None

Applicants should email a recent curriculum vitae or résumé and a cover letter to applications@ismpp.org by May 4, 2015.

 

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Position: Global Publications Lead
Company: AstraZeneca
Location: Cambridge, UK or Gaithersburg, MD

Global Publications Leader – Respiratory, Immunology and Autoimmune (RIA)
We’re currently seeking a Global Publications Leader in RIA, preferably with heavy respiratory experience, to lead the development and execution of strategic, global publication plans. You’ll be responsible for ensuring compliance with our policy and enhancing our external scientific reputation. This exciting role offers you the chance to work globally, and the opportunity to work with the marketing companies and several collaborations.

About AstraZeneca
At AstraZeneca, a biopharmaceutical company, each and every one of us is bold in the belief that science should be at the center of everything we do. We believe that science can change the way we see the world and how we can impact the diseases that impact us. AstraZeneca is a place where free thinking and creativity fuel our determination to make a difference to people’s lives through science.

As a Global Publications Leader – RIA, it’s essential that you have:

  • A post-graduate degree (preferred), with proven scientific and publication expertise

  • Demonstrated experience in medical communications, gained through working in the pharmaceutical industry or a medical communications agency

  • Experience working globally, cross-culturally and cross-functionally 

  • Demonstrated proven project management skills experience in a complex multidisciplinary environment

  • A broad knowledge of the relevant disease areas

The following skills and qualifications are desirable:

  • Strong leadership experience, with exceptional interpersonal, communications and influencing skills

  • The ability to establish and maintain professional relationships with external experts, investigators, journal editors and publishers

  • The ability to effectively manage multiple stakeholders and projects within budget

  • Flexibility and adaptability to manage long-term activities in a constantly changing internal and external environment

  • Broad therapeutic knowledge with proven ability to adapt quickly to therapeutic specialties

 

As a Global Publications Leader – RIA , your main responsibilities will involve:

  • Leading the development and execution of strategic , global publication plans to include clinical studies, translational science, and real world evidence data into publications for prescribers, payers, and patients 

  • Tracking existing publication plans by brand to ensure alignment with product and evidence plans

  • Overseeing the generation of a quarterly metrics

  • Leading the day-to-day management of assigned publication plan tactics, delivery of outputs, financial tracking and additional meeting activities

AstraZeneca welcomes applications from all sections of the community. AstraZeneca is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

Please  visit the AstraZeneca Career site for more information.

 

 

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Position: Medical Copy Editor
Company: Springer Healthcare
Location: New York, NY

The Medical Copy Editor is responsible for proofreading, editing, and styling manuscripts and other medical communication initiatives. He/she will also prepare manuscripts for submission to journals. The individual should be familiar with proofreading/editing for the medical communications and pharmaceutical field, possess a mastery of AMA and APA styles and be adept in a variety of software including, but not limited to MS Word, Excel, PowerPoint, EndNote and Adobe Acrobat Professional. 

JOB DESCRIPTION:

Specific responsibilities include:

A. Provide thorough review and editing for a variety of medical communications, including 
  • Journal articles (primary, secondary, and review articles) 

  • Product monographs 

  • Abstracts, posters, and slide decks for scientific meetings 

  • Competitor intelligence reports 

  • Medical slide decks 

  • Pharmaceutical sales training materials

B. Review each piece for grammar, punctuation, style, consistency, individual brand style/design and overall flow and clarity in accordance with AMA/journal style
C. Format/style all references using EndNote
D. Prepare manuscripts for journal submission

E. Page Proofs

  • Conduct detailed review of journal page proofs using Adobe Acrobat (comparing to the submitted word copy), make comments/edits to page proofs ensuring that final article was ready for publication

F. Any other duties as required

QUALIFICATIONS & EDUCATION: 

  • BS degree (English and/or life science required)

  • 5+ experience in medical communications, pharmaceutical industry/healthcare, or publishing (preferred)


Please apply using our online application system

 

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Position: Medical Publication Lead Neurology & Immunology
Company: Merck KGaA
Location: Darmstadt, Germany or Boston, MA

The Medical Publication Lead drives the medical publication strategy formulation in alignment with the program team, including the alignment with relevant functions like Clinical or Medical Affairs. The Medical Publication Lead is accountable for the delivery of the publication items and leads the Medical Publication Managers in operationalizing the strategic publication plan, through building and leading a high-performing team.

JOB DESCRIPTION:

  • Leads the medical publication strategy formulation in alignment with the global program teams for Neurology (incl Rebif) and Immunology (incl Atacicept)

  • Integrates cross-functional, global and local needs into one strategic plan

  • Communicates strategic and complex concepts in a simple manner to multidisciplinary teams

  • Direct line management of Medical Publication Managers

  • Details the comprehensive strategic publication plans in alignment with Publication Managers

  • Ensures Publication Managers are delivering medical publications according to publication plan and predefined quality criteria

  • Compares to industry standards, identifies areas for improvement and develops recommendation for implementation to improve processes and procedures for operational delivery

  • Is accountable and responsible for the delivery of the publication plan within budget and timeline

  • Manages service levels with external vendors and consultants

  • Builds good and trustful relationships with external authors on a very high level, contributes to the improvement of our external stakeholder approach

  • Represents the company at congresses

  • Ensures compliance with all relevant internal and external regulations with a clear sense of how to protect the company reputation

  • Approaches evolving compliance topics proactively

  • Guides and influences peers within on a mid to higher management level

  • Serves as trusted authority and expert within the company for medical publications.

  • Proactively identifies solutions to problems or bottlenecks, using advanced analytical skills to solve complex topics

  • Drives forward joint solutions with understanding of the needs and objectives of the different involved functions and departments

  • Aligns his/her own deliverables with other parts of the business, has highly strategic view on how to contribute to company goals


QUALIFICATIONS AND EDUCATION:

Preferred Skills and Experience:

  • Advanced university degree in science or biomedical subject, preferably PhD

  • Scientific expertise in neurology/immunology a plus

  • Fluent in spoken and written English, basic knowledge of second language (German, French) a plus

  • A minimum of 10 years professional experience in an international pharma/ biotech setting in various aspects of drug development process, preferably clinical, biostatistic, regulatory, safety or medical.

  • A minimum of 8-10 years experience in a pharma/biotech medical publication department or medical communication agency

  • Several years of international experience and demonstrated success in managerial position(s)

  • Proven track record of successful medical publication strategies and deliverables

  • Significant project management experience

  • Problem solving orientation and clear outcome focus

  • Clear sense of accountability

  • Good leadership skills

  • Strong interpersonal skills

  • Excellent verbal and written communication skills

  • Capability to participate in complex strategy formulation. Lateral thinking capability is vital

  • Ability to represent the company and to negotiate at all levels internally and externally

 

Merck – with more than 300 years of progress and about 38,000 employees in over 60 countries, we are leading in pharma, chemicals and life sciences. With passion, dedication and innovative ideas, we pursue one global goal: to improve people’s quality of life. Like to join in?
Welcome to the team!

Apply online: www.merckgroup.com/careers; Job number 53323

 

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Position: Medical Publication Manager Oncology / Immuno-Oncology
Company: Merck KGaA
Location: Darmstadt, Germany or Boston, MA

The Medical Publication Manager drives and manages the implementation of the medical publication plan for specific compounds/ products, operationalizing the publication strategy in close collaboration with the Medical Publication Lead. The Medical Publication Manager coordinates core teams to develop specific publication items together with external and internal authors.

JOB DESCRIPTION:

  • Works in close collaboration with Medical Publication Lead to detail and implement the publication strategy for the specific compounds/products

  • Drives and manages the implementation of the publication plan with responsibility for respective budget & timeline

  • Drives the delivery of high quality medical publications together with cross-functional Publication Subteam (e.g. Medical Lead, Biostats Lead etc)

  • Chairs selected Publication Subteam meetings and supports development of innovative approaches and perspectives

  • Manages delivery of all publication items detailed in the publication plan, meeting predefined quality thresholds and achieving set targets

  • Guides external vendors and consultants

  • Fosters good and trustful relationships with external clinical and academic partners and publishers

  • Manages author interface with external and internal authors, promotes and supports good publication principles

  • Ensures compliance with all relevant internal and external regulations with a clear sense of how to protect the company reputation

  • Contributes to the continuous improvement within the department

  • Builds a strong interface with all relevant function, acts as advisor and mentor within the Medical Publication team and beyond

  • Proactively identifies solutions to problems or bottlenecks, using advanced analytical skills to solve complex topics

  • Drives forward joint solutions with understanding of the needs and objectives of the different involved functions and departments

  • Aligns his/her own deliverables with other parts of the business   

 

QUALIFICATIONS AND EDUCATION:

  • Desired Skills and Experience:

  • Advanced university degree in science or biomedical subject, preferably PhD

  • Scientific expertise in oncology or immuno-oncology a plus

  • Fluent in spoken and written English, basic knowledge of second language (German, French) a plus

  • A minimum of 8 years professional experience in an international pharma/ biotech setting in various aspects of drug development process, preferably clinical, biostatistic, regulatory, safety or medical.

  • A minimum of 6 years experience in a pharma / biotech medical publication department or medical communication agency

  • Proven track record of successful medical publication delivery either in pharma / biotech company or medical communication agency

  • Strong project management and project leadership skills

  • Advanced analytical skills and ability to understand complex processes

  • Problem solving orientation and clear outcome focus

  • Clear sense of accountability

  • Strong interpersonal skills                            

  • Excellent verbal and written communication skills

 

Merck – with more than 300 years of progress and about 38,000 employees in over 60 countries, we are leading in pharma, chemicals and life sciences. With passion, dedication and innovative ideas, we pursue one global goal: to improve people’s quality of life. Like to join in?
Welcome to the team!
 
Apply online: www.merckgroup.com/careers; Job number 65465

 

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Position: Medical Publication Manager Immunology
Company: Merck KGaA
Location: Darmstadt, Germany or Boston, MA

The Medical Publication Manager drives and manages the implementation of the medical publication plan for specific compounds/ products, operationalizing the publication strategy in close collaboration with the Medical Publication Lead. The Medical Publication Manager coordinates core teams to develop specific publication items together with external and internal authors.

JOB DESCRIPTION:

  • Works in close collaboration with Medical Publication Lead to detail and implement the publication strategy for the specific compounds/products

  • Drives and manages the implementation of the publication plan with responsibility for respective budget & timeline

  • Drives the delivery of high quality medical publications together with cross-functional Publication Subteam (e.g. Medical Lead, Biostats Lead etc)

  • Chairs selected Publication Subteam meetings and supports development of innovative approaches and perspectives

  • Manages delivery of all publication items detailed in the publication plan, meeting predefined quality thresholds and achieving set targets

  • Guides external vendors and consultants

  • Fosters good and trustful relationships with external clinical and academic partners and publishers

  • Manages author interface with external and internal authors, promotes and supports good publication principles

  • Ensures compliance with all relevant internal and external regulations with a clear sense of how to protect the company reputation

  • Contributes to the continuous improvement within the department

  • Builds a strong interface with all relevant function, acts as advisor and mentor within the Medical Publication team and beyond

  • Proactively identifies solutions to problems or bottlenecks, using advanced analytical skills to solve complex topics

  • Drives forward joint solutions with understanding of the needs and objectives of the different involved functions and departments

  • Aligns his/her own deliverables with other parts of the business

 

QUALIFICATIONS AND EDUCATION:

Desired Skills and Experience:

  • Advanced university degree in science or biomedical subject, preferably PhD

  • Scientific expertise in immununology a plus

  • Fluent in spoken and written English, basic knowledge of second language (German, French) a plus

  • A minimum of 8 years professional experience in an international pharma/ biotech setting in various aspects of drug development process, preferably clinical, biostatistic, regulatory, safety or medical.

  • A minimum of 6 years experience in a pharma/ biotech medical publication department or medical communication agency

  • Proven track record of successful medical publication delivery either in pharma/ biotech company or medical communication agency

  • Strong project management and project leadership skills

  • Advanced analytical skills and ability to understand complex processes

  • Problem solving orientation and clear outcome focus

  • Clear sense of accountability

  • Strong interpersonal skills                            

  • Excellent verbal and written communication skills

Merck – with more than 300 years of progress and about 38,000 employees in over 60 countries, we are leading in pharma, chemicals and life sciences. With passion, dedication and innovative ideas, we pursue one global goal: to improve people’s quality of life. Like to join in?
Welcome to the team!
 
Apply online: www.merckgroup.com/careers; Job number 59464

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Position: Medical Writer
Company: Medtronic
Location: Goleta, CA

The Medical Writer is responsible for creating and ensuring the scientific validity of clinical-related documentation generated by Surgical Technologies. Specifically, the incumbent must ensure high-quality scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines. The incumbent performs all duties while adhering to the Quality System.

  • Incumbent is responsible for technical and medical writing support for the Clinical Affairs organization across the business sector, including but not limited to, the following:

  • Incumbent is responsible for technical and medical writing support for the Clinical Affairs organization across the business sector, including but not limited to, the following:

  • Analyzing clinical evidence of all kinds (e.g., public, proprietary, published, unpublished) from all sources (e.g., journals, internal documents, regulatory submissions) in order to assist Clinical Affairs colleagues and management with project proposals and departmental strategies. Understanding levels of evidence required to achieve regulatory, marketing, and regulatory goals.

  • Conducting comprehensive literature searches and performing critical evaluation of the risks/benefits of devices/therapies for generation of new and maintenance of existing Clinical Evaluation Reports (CERs) in compliance with the Medical Device Directive for product clearance/certification in Europe. Assessing on an ongoing basis the quality, scientific validity, and audit-readiness of CERs.

  • Periodically reviewing medical literature for new information that may warrant supplemental updates to CERs as applicable (e.g., if new risks are identified) and for reporting of Medtronic device-related adverse events (AEs) to Customer Loyalty/Product Experience.

  • Bachelor’s degree in a science, medical, English language, communication, or other technical discipline and minimum two years medical writing work experience, preferably medical device Regulatory Affairs and/or Clinical Affairs; OR

  • Master’s degree in a science, medical, English language, communication, or other technical discipline with no experience.

  • Authorship or acknowledged contributorship on published, peer-reviewed medical abstracts/manuscripts and/or significant work experience in publication development in the medical device, pharmaceutical, or biotechnology industries, including:
    • Experience in the editorial development and preparation of manuscripts in scientific format;
    • Accurate description and presentation of clinical trial methods, statistical parameters, and medical data
    • Advanced knowledge of scientific peer-reviewed journal submission requirements.

Interested candidates should apply at www.medtronic.com/careers.

 

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Position: Medical Writer
Company: Vaniam Group
Location: Virtual Company

The Medical Writer will oversee projects by coordinating and tracking project plans, resources, and timelines. The individual will develop project schedules, facilitate documentation of client and team meetings, and update ProWork Flow to ensure timely and cost effective achievement of project milestones. The individual plays a critical role in managing client satisfaction and relationships. In addition, this role is responsible to support business improvement by meeting personal and departmental goals and objectives timely and effectively.

Job Description:

Key responsibilities include, but are not limited to the following:

  • Oversee the development of projects, ensuring strategic planning and implementation and alignment with client objectives

  • Assist with development of project strategy with internal team and client team

  • Assess project issues and challenges, and identify and implement solutions to meet productivity, quality and client goals as well as compliance standards

  • Edit and write content, as needed, for slides, training modules, and other scientific communications deliverables

  • Build strong partnerships with client teams

  • Respond promptly to client needs and requests for service and assistance, and provide guidance to Vaniam Group scientific communications team.

  • Managing scientific communications advisory board flow:

  • Attend regular status meetings with client project team, internal teams, and external contractors to ensure effective communication, work quality, project flow and process, and timeline development

  • Understand and communicate client requirements to appropriate team members, and manage all requirements accordingly

  • Coordinate writing activities of internal writing team

Note: These are the major functions and accountabilities required of the position and are the predominant criteria by which performance will be assessed.  OTHER DUTIES AS ASSIGNED.


QUALIFICATIONS AND EDUCATION: 

EDUCATION:

  • Minimum: Master’s degree in science, PhD, PharmD preferred

 

EXPERIENCE AND SKILLS:

  • A minimum of two years of work experience in an agency, the pharmaceutical industry, or a related scientific or medical writing position

  • Expertise as a Oncology/Hematology Medical Writer

  • Expertise as a scientific communications professional

  • Commitment to ethical and transparent data dissemination standards

  • Leadership in upholding and fostering integrity and excellence in scientific communications

  • Computer programs systems: Highly Proficient with the following MS Office (Word, Excel, Powerpoint, Adobe Acrobat) Outlook, Google or similar calendar system, familiarity with Endnote, DropBox and Webex (or other similar systems) preferred

  • Demonstrated ability to work collaboratively in a dynamic environment 

  • Demonstrated leadership skills and ability to prioritize and plan work activities, use time efficiently, plan for additional resources, set goals and objectives, organize other people and other tasks 

  • Excellent interpersonal, organization, verbal and written communication skills

  • Excellent quantitative and analytical skills and ability to synthesize complex or diverse information

  • Excellent problem-solving skills including the ability to analyze information skillfully, develop alternative solutions, and work well in group problem solving solutions 

  • Strong attention to detail

  • Ability to meet tight deadlines

  • Travel within the US and internationally as necessary, based on project, sponsor and organizational needs (>30% travel expected)

 

For more information, please contact eva@bioconnections.com

 

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Position: Medical Writer
Company: Springer
Location: New York, NY

JOB DESCRIPTION:
To prepare scientific content of medical communications that satisfy client needs in terms of quality, commercial focus, timing and cost. Specific responsibilities include:

Project work

  • Write and edit scientific content for a range of medical communications, according to client needs, deadline, budget and internal quality standards, as directed by the Scientific Services Team Leader

Business Planning/commercial

  • Contribute to account plans, strategic publication plans and publication programs, where appropriate, by maintaining current awareness of developments in therapeutic area or discipline and the Springer Healthcare product portfolio.

  • Present to clients the results of activities, when required, e.g. publication plans, results of competitive intelligence reports, and to contribute to client brainstorming meetings.

Financial

  • Monitor own adherence to budget and utilization rate

Organizational

  • Support team working principles within the business unit, account team and other departments and collaboration between business units by attending team and editorial meetings/tutorials 

  • Record and monitor actual time spent on a project against budgeted time, and complete timesheets in an accurate and timely manner.


QUALIFICATIONS AND EDUCATION:

  • At least one (1) year in as a writer for a medical communication agency or as an internal medical communications writer for a pharmaceutical, healthcare, clinical research, academic research or publishing company

  • Degree in Life Science or pharmacy, pharmacology or medicine (or equivalent); PhD, PharmD or MD preferred

  • Working knowledge of MS Office suite and referencing software (ie, Endnote, Refman, etc.)


Please apply using our online application system

 

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Position: Publication Manager, Hematology
Company: Bristol-Myers Squibb
Location: Princeton, NJ

The primary responsibility for the Publications Manager is in the co-development and co-delivery of a comprehensive, globally aligned strategic publication plan that reflect priorities for the WM key markets (US, FR, GER, JAP). The Publication Manager will primarily co-manage publication plans and activities for large, complex brands or for multiple brands within a therapy area while under the direct mentorship of skilled publication team members such as the Publication Lead. The Publication Manager will be deployed to the Global Medical Team and the US Medical Matrix Team for their responsible products. 

JOB DESCRIPTION:

  • Supports a high performing, cross-functional global publication matrix team engaged in the planning, integration and execution of medical publication activities globally; 

  • Translates medical strategies and objectives into actionable long-term strategic publication plans; plans that are comprehensive (representing all functions and key markets with ongoing data generation) and globally aligned; 

  • Ensures approval and endorsement of publication plan by governance bodies (WWMT, FDT) prior to execution; continuously evolves plan in conjunction with scientific landscape; 

  • Works to build and demonstrate understanding of the disease area, medical strategies and objectives necessary to provide strategic input to a broad range of stakeholders on matters related to publication planning &data dissemination/disclosure under the direct mentorship of a Global Publication Lead; 

  • Supports effective and consistent strategies for engaging external expertise (e.g. Publication Steering Committee) to advise and shape publication plan strategy; 

  • Fosters collaborative relationships with academic and clinical experts, publishers, medical associations & other relevant stakeholder groups; 

  • Partners on the execution of the publication platform at prioritized International and domestic congresses (abstracts, presentations); 

  • Reviews publication drafts for scientific quality and to ensure alignment & consistency with author direction, the scientific communication platform and key communication points supported by data; 

  • Manages author (external and internal) interface to ensure timely execution and delivery of publications in accordance with GPP3 and BMS processes;

 

QUALIFICATIONS AND EDUCATION:

  • Advanced degree: PharmD, PhD or MD in a science subject or biomedical degree preferred; bachelor’s degree in biomedical discipline or equivalent with in depth experience in publication management considered 

  • A minimum of 1-5 years experience within the pharmaceutical or related healthcare industry, in both a regional and global capacity 

  • Working knowledge of scientific publication strategy, planning and execution during all phases of drug development and commercialization process (investigational, registrational, pre & post-launch and marketed) 

  • Scientific expertise in the disease/therapeutic area preferred 

  • Experience working in highly matrix environment across a broad range of functional areas and effectively collaborating with the Medical Affairs, Health Outcomes, R&D, regulatory, legal and commercial teams 

  • Understanding of the clinical trial design and execution, statistical methods and clinical trial data reporting requirements 

  • Understanding of good publication practices and guidance (GPP2, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication 

  • Outstanding interpersonal, written and verbal communication skills with exceptional time management skills are required for this highly visible global position 

  • Working knowledge of Microsoft Suite applications and familiarity with publication management tools & systems (Datavision) 

  • Ability to travel domestically and internationally approximately 20 – 25% of time

 

Please apply at: www.bms.com/careers, Job ID:1501426

 

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Position: Regulatory/ Scientific Communications Medical Writer
Company: MED Institute
Location: West Lafayette, IN

MED Institute Inc. needs additional experienced Regulatory and Scientific Communications Writers. These writers will act as in-house consultants for MED Institute  as well as for other Cook Group companies. Writers will use their regulatory skills and scientific knowledge to bring innovative device technologies to market and/or to disseminate scientific data relevant to medical devices. Opportunities, responsibilities, and compensation will be commensurate with background, skills, and experience. Writers will perform duties specific to both the Regulatory and the Scientific Communications teams at MED Institute.

JOB DESCRIPTION:

  • Provide organization, direction, and regulatory leadership to a project team for approval of new medical devices;

  • Provide regulatory-based guidance through all phases of a project (research and development, pre-clinical and clinical testing, final data analysis, and preparation of regulatory submissions);

  • Provide interpretation and analysis of clinical and non-clinical data pertinent to scientific communications projects (e.g., literature reviews, abstracts, posters, presentations, manuscripts, Clinical Evidence Reports, and clinical study reports);

  • Write and/or direct the preparation of clear and effective documents; and

  • Fulfill the ICMJE requirements for authorship for scientific communications projects, when appropriate.

 

QUALIFICATIONS AND EDUCATION:

  • Hold a Masters, MD, or PhD in a scientific or an engineering discipline or have equivalent regulatory/writing experience;

  • Have experience with literature searches and manuscript preparation;

  • Demonstrate familiarity with statistical methods, analysis, and interpretation;

  • Communicate clearly and concisely in both spoken and written form; 

  • Be able to work on multiple projects (i.e., multi-task), organize, and prioritize within time constraints;

  • Be familiar with Microsoft Office software; and

  • Commit to participate in a team-based environment.

  • Familiarity with the components of regulatory submissions (IDEs, PMAs, 510(k)s, INDs, and NDAs) is beneficial.

Interested?
To apply for this position please go to https://www.cookmedical.com/careers and search for this position. Click on the position title to open the position description and submit your application.

 

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Position: Senior Medical Writer
Company: Springer Healthcare
Location: New York, NY

JOB DESCRIPTION:
Specific Responsibilities:

Write and manage delivery of scientific content for a range of medical communications that meet client needs, internal quality standards and timelines: 
  • Act as Lead Writer for one or more major accounts and provide the main point of contact on matters of scientific content for the client and KOLs
  • Provide editorial quotes for costing purposes
  • Advise Assistant Scientific Services Director and Scientific Services Director about resource requirements
  • Recommend authors, publications and target journals
  • Address journal peer review comments
To review scientific content for range of medical communications, according to client needs, internal quality standards and agreed specifications, budgets and timeframes:
  • Monitor quality, style and accuracy and provide timely, consistent and constructive feedback 
  • Ensure that projects reflect a thorough understanding of clients’ objectives Maintain broad awareness of developments in relevant therapeutic areas and discipline, editorial issues within publishing and the Springer Healthcare product portfolio
  • Contribute to revenue targets by ensuring that projects are progressed as soon as possible after confirmation
  • Monitor own adherence to budget and utilization rate
  • Record and monitor actual time spent on a project against budgeted time, and complete timesheets in an accurate and timely manner
  • Apply knowledge of the therapeutic use and strategic marketing of pharmaceuticals to account plans, strategic publication plans, strategic communication programs, proposals and pitches
  • Participate fully in briefing and brainstorming meetings
  • Provide scientific expertise to Business Development in the development of new business pitches and proposals

Managerial Responsibilities:
In conjunction with the Scientific Services Director and Assistant Scientific Services Director(s), help develop writers within an account team to achieve their full potential:

  • Coach and mentor junior writers as required
  • Assist the Scientific Services Team Leader and Scientific Services Director in preparing and updating SOPs/training modules and in delivering editorial training in relevant therapy area/discipline

  • Contribute to or conduct (as appropriate) performance and learning & development reviews and develop and monitor progress of objectives with direct reports

  • Assist the Scientific Services Team Leader and Scientific Services Director in recruitment by interviewing candidates if required 

  • Support team working principles within Medical Communications, account team and other departments and collaboration between business units by attending team and editorial meetings/tutorials

QUALIFICATIONS AND EDUCATION:

  • BSc/BA, preferably in life sciences -- PharmD, MD or PhD preferred

  • Minimum of 3 years’ experience in medical writing within in a medical communications agency or publishing environment

Other Skills:

  • An excellent understanding of the pharmaceutical industry and the drug development process

  • Experience in data handling and analysis

  • Excellent writing, editing, and organizational skills

  • Proficiency with Word, PowerPoint and other Microsoft packages 

  • Ability to work in a team environment

  • Ability to manage multiple writing projects at one time

  • Ability to work independently

 

Please apply using our online application system

 

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Position: US Publications Lead
Company: AstraZeneca
Location: Wilmington, DE or Gaithersburg, MD

Our US Medical Affairs Department currently has two Publications Lead positions available – one in Respiratory, based in Wilmington, DE and another in Oncology, based in Gaithersburg, MD. As the Publications Lead you will be responsible for leading the development of US Publication strategies and plans to support your therapy area and you will oversee the delivery of the medical, scientific and technical publications included in these plans in accordance with AstraZeneca policies and relevant external guidelines. Execution of these responsibilities will involve close collaboration with Clinical Leads, HEOR Directors and external authors to publish results of new studies. You will also collaborate with Global Publications Leads, other US Medical Affairs stakeholders and external authors to identify and understand existing knowledge gaps in the external medical community and support the delivery of data analyses and educational review manuscripts to address those gaps.

The ideal candidate will have an advanced biomedical degree with excellent written and oral communication skills, in depth knowledge of external publication guidelines and standards and direct experience in publication planning and development activities within a pharmaceutical company or a communications agency. Experience managing agencies, budgets, and working with electronic publication planning systems is preferred (but not required) and knowledge of respiratory or oncology therapy areas would also be beneficial.

To apply for one of these positions, please visit:

 

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